r4 Manuale Isykone Eng
r4 Manuale Isykone Eng
r4 Manuale Isykone Eng
MANUAL
IMPLANT LINE
ISY KONE
For detailed information on other specific implant lines and their restorative procedures,
please refer to the corresponding manuals, specific literature or refer to the BTK website.
Consider to regularly visit practical courses for updates and professional exchange
with dedicated colleagues in order to ensure your long-term success with implant-borne den-
tal restorations.
1. CORPORATE BACKGROUND 6
2. IMPLANT SELECTION 8
3. IMPLANT CHARACTERISTICS 10
4. IMPLANT PORTFOLIO 12
5. IMPLANT INSERTION PROCEDURE 14
6. SURGICAL KIT, TORQUE WRENCH AND DRILLS 16
7. SURGICAL PROTOCOLS 22
8. ADDITIONAL INSTRUMENTS 20
9. MORSE TAPER MTH KN/KR 26
10. INTERNAL HEXAGON INT IR/IW 30
11. EXTERNAL HEXAGON EXT EN/ER 35
12. OVERDENTURE 40
13. MATERIAL SPECIFICATIONS 42
14. LABELS SYMBOLS 44
15. DELIVERY TERMS AND CONDITIONS 45
CORPORATE BACKGROUND
Privately held BTK BIOTEC was founded in 1998 in order to improve the quality of life of people
with missing teeth.
BTK is a dedicated supporter of the genuine “100% Made in Italy” label, because with this it is
guaranteed that BTK products are of unmatcheable Italian craftsmanship and premium quality
materials offering dedicated specialization and ample differentiation.
Implanting Trust,
Smile again!
By combining cutting-edge technologies and biology, BTK’s mission is to offer affordable and
personalized implant-borne solutions thereby sustainably improving the daily life of dental patients.
Grade 4 commercially pure titanium Clinical trials confirm that roughened The precision of the connection between
(ASTM F 67 / ISO 5832-2) is BTK’s material endosseous surfaces perform better than implant and abutment creating a tight
of choice for dental implants. Grade 4 is machined surfaces concerning endosseous seal may be beneficial in preventing
slightly harder to work, but it provides wound healing, “de novo” bone formation inflammatory bacteria propagating in the
the highest strength and durability and reduced time-to-loading. interface between different components.
characteristics among the commercially
pure titanium grades, making it the natural Our DAE (dual- acid-etched) process aims Apart from that, extremely tight
choice for BTK dental implants. to obtain a moderately rough surface with tolerances as applied by BTK help to avoid
a controlled micro-roughness. micromovements.
Grade 5 titanium (ASTM F 136 / ISO 5832- Providing precision in every part produced
3) is used for BTK’s prosthetic components, is one of our key contributions ensuring
as these are subject to certain levels of longterm restorative success.
stress and in the MINI line implants.
This high-strength version, also known as
Ti-6Al-4V, is widely used in orthopedics
and shows excellent long-term physical
and mechanical properties.
The purpose of dental implant therapy, now widely used in We constantly ensure that the quality of our products and services
dentistry, is to replace lost dental elements with biocompatible meet the high expectations of our customers and their patients.
titanium implants, in order to obtain a new and correct occlusion, Specialized professionals are taking care to offer comprehensive
using prostheses on implants. solutions in applied research, engineering, education and related
activities.
In order to achieve this goal, BTK offers a focused portfolio
of restorative solutions backed-up by comprehensive clinical Our brand is a solid promise of quality, we are certified UNI EN
experience. BTK offers a variety of prostheses components to ISO 9001, UNI EN ISO 13485 and MDD 93/42/EEC and subsequent
satisfy the clinical preferences and needs of the patients. amendements and additions, and is therefore authorized to apply
the CE Mark on its products.
IMPLANT
PORTFOLIO
BTK is dedicated to offer comprehensive implant solutions to meet the requirements of individual
clinical situations, user preferences and economic constraints.
Different designs, sizes, diameters, surfaces and abutment connections are available,
while at the same time BTK strives to maintain a small number of precision-instruments
thus simplifying procedures and limiting investments needed.
PARALLEL BT KLASSIC
ISY KONE
DRILLING
PROTOCOL ISY+ / BT SAFE / BT NANO
TAPERED BT KONIC
IV III II I
BONE DENSITY
BTK’s morse-taper hexagon BTK’s internal hexagon connection BTK’s external hexagon connection
connection comprises a 2.6 mm comprises a parallel hexagon of 2 mm comprises a parallel hexagon at 0.7 mm
conical portion at 11° above a hexagon length opening with a small conical portion height and a 90° shoulder to allow a flat-to-
configuration combined with a M1.4 (KN), combined with a M1.8 abutment screw to flat margin fit to the implant. Abutments are
M1.6 (KR/DR) or M1.8 (KW) abutment deliver adequate pre-load with a minimum connected to the implant using a M1.8 (EN)
screw to deliver adequate pre-load with a of tightening. or M2.0 (ER/EW) abutment screw.
minimum of tightening.
The internal hexagon has two functions: The abutment screw plays a central role
Implants with a tapered interface can resist to transfer the torque momentum during for the mechanical, long-term strength and
larger axial and transversal forces than implant placement and as an indexing fatigue resistance of the implant abutment
implants with a flat interface. system to transfer the precise 3D-position of connection. The requirements for such a
The design guides the abutment into a the implant to the master cast. screw are many, such as no loosening, long-
predictable location with a precise fit with term fatigue resistance, overload protection
the inner portion of the implant. Internal indexing systems have some and safe pick-up and handling ability.
advantages over external indexing systems
The precision of the conical connection with since they allow longer engaging surfaces Due to the fact that the abutment screw is
its tight seal may be beneficial in preventing while reducing the platform height of exposed to heavy dynamic loads, the precise
inflammatory bacteria from propagating in the implant. This offers somewhat more application of tightening torque force is
the interface between implant and abutment flexibility in designing the emergence profile essential.
and it helps to avoid micro-movements. of the final restoration.
NOTE that different BTK implants require different types of prosthetic platforms using corresponding abbreviations according to their sizes. For more
details, refer to the corresponding BTK implant lines documentation.
3 DIFFERENT CONNECTIONS
SMOOTH,
BACK-TAPERED
NECK ZONE
MICRO-THREADED
CRESTAL ZONE
SINGLE-LEAD SQUARE
THREAD WITH 0,9 MM PITCH
TAPERED BODY
CP TITANIUM
GRADE 4
DAE TEXTURED
SURFACE
ROUNDED-OFF
“APEX”
IDENTICAL ENDOSSEOUS
DESIGN
IMPLANT
CHARACTERISTICS
This bone-level, root-shaped and self-tapping implant offers a back-tapered, micro-threaded smooth neck portion of
0,8-1,15 mm and is well suitable for most indications. ISY KONE is placed at bone level and offers both, healing modes.
The single-lead square thread pitch on ISY KONE measures 0,9 mm for all diameters including Ø 2.9 mm / Ø 3.3 mm /
Ø 3.7 mm / Ø 4.1 mm / Ø 4.8 mm / Ø 6 mm.
ISY KONE is a highly versatile type of implant line as it offers three different abutment connections either
external (EXT) or internal (INT) hexagon, or as a third option the well-proven 11° (MTH) hexagon having regular
(KR) and narrow (KN) corresponding prosthetic components. It shares the surgical kit with BT SAFE, BT NANO and ISY+.
C
C C
A A A
B B B
D D D
The color codes applied for different implant diameters and prosthetic platforms are indicated below:
HANDLING OF STERILE
IMPLANT PACKAGING
CAUTION
The sealed package of the medical device (MD) must be opened in a surgically suitable environment.
The removal of the implant and of the cover screw, if provided, must be carried out using sterilized instruments, avoiding any contact with non-sterile surfaces.
The sterility of the medical device is only guaranteed if the following conditions are met:
the expiry date stated on the packaging is still valid; there is a red dot on the sterile vial that signals the successful operation of gamma ray irradiation; the sealed package has
not been opened and does not show damage or perforations.If only one of the aforementioned conditions is not respected, the device must not be used.
The device is disposable; the reuse can compromise the safety features of the device making it inappropriate for its intended use. BIOTEC explicitly declares that the MD is for
single use and assumes no responsibility for any re-use by users.
1 2 3
BTK dental implants are supplied sterile in a Open the blister from the back by breaking the The top lid of the vial is protected by the seal
double-vial package. The implant diameter, outer label, and take out the vial. label. The color of the seal label identifies the
length and lot are shown on the label located in diameter of the implant. To facilitate compliance
the vial containing the implant and in the outer with the traceability requirement of the medical
label on the back of the packaging. device, there are two detachable patient-labels
in the vial. One must be stuck onto the patient’s
medical record and one onto the patient’s
implant passport.
4 5 6
Open the external vial and withdraw the internal Remove the safety cap of the sterile inner vial, Some implant lines are supplied with mounting
vial containing the implant in a surgically suitable which always includes the sterile closure screw. device connected to the implant, other lines are
environment. The internal vial must be handled WARNING The internal vial consists of 3 parts. supplied without.
with sterile gloves. The cover screw (locking screw), if provided, is Depending on the different configuration, use
placed in the vial cap. the appropriate instrument for the implant
Hold the vial upright to prevent the devices from withdrawal from the vial and for the insertion
leaking out. of the same in the previously prepared implant
Unscrew the central part of the vial, to access site.
the implant. The BTK dental implants can be positioned
manually with the Reversible Torque Wrench
or they can be inserted using the contra-
angle handpiece. A range of 15 - 25 rpm is
recommended for implant insertion and not to
exceed the maximum torque indicated by BTK.
If a (partial / complete) tapping has been performed before implant insertion, the
implant should be placed carefully on the implant site by performing a counterclockwise
half rotation to engage the implant with the prepared thread.
After inserting into the thread, the implant can be guided in its final position clockwise,
making sure that the implant is inserted at the desired depth and that the connection
is intact.
WARNING The “implant driver” insertion drivers for the Morse-taper hexagon implant
connection must be removed with delicate off-axis movements before removing them.
In the cap of the internal vial there is, for each implant family, the corresponding cover
screw (locking screw), sterile and ready for use.
Use sterile saline solution to carefully clean the implant connection from any organic
residues. Therefore, make sure that it is clean and dry, before placing the cover screw
(locking screw) or any prosthetic components that have been decided to be connect to
the implant.
The cover screw is the chosen solution for the closed healing mode. To remove it more
easily at the end of the healing period, a small amount of sterile vaseline or sterile
chlorhexidine gel can be applied to the thread of the cover screw or healing cap
before tightening it manually (5-8 Ncm) on the BTK implant, using a driver with a hex
connection.
SURGICAL KIT
624NA001
1 2 3
8 9
10
12
11
1
GUIDE SHAFT
502MA002 Ø 2.5 mm
2
1 6 ANGLED WRENCH 30°
502MA003 HEX 3.10
2
7
3
3 DEPTH GAUGE
8 540MA011 Ø 1.8 mm L108 mm 30°
4
4
5 9
SURGICAL GUIDE BT4
502MA006 (PIN Ø2.5mm)
5
TORQUE WRENCH JD,
REVERSIBLE
18 ISY KONE MANUAL 501JD003 90 Ncm
6 10
1
TAPS ISY KONE SCREWDRIVER JD
SHARP LANCE DRILL
TAPS BT SAFE
426HR310 Ø 2,75 - 3,10 mm L36.5 mm 518NA505 H5 mm Snap Fit
435ER001 ER 9
540MA019 Ø 2-2,5 mm
435IR001 IR L26 mm 2 pcs RETENTIVE WRENCH
435KR001 KR
518NA716 H16 mm Snap Fit
435KW001 KW 530HS017 HEX 3.10
CHARACTERISTICS
OF SURGICAL DRILLS
• All drills and screw taps are made of stainless steel.
• All drills and screw taps are supplied in non-sterile single packs or in kit not sterile.
Please refer to the recommendations on cleansing and sterilization indicated by BTK.
• Drills and screw taps must be replaced after a maximum of 20 uses.
The effectiveness decreases after 5/6 applications already.
• All drills and screw taps have depth markings made with laser technique.
• The length relative to the corresponding black strip, realized with laser technique,
it is always the lower or upper end of the strip.
• The black strips correspond to the length of the selected implant.
However, to increase security, the drill stops can be used during site preparation.
• All drills report their diameter and the relevant reference code on the stem.
• All final drills allow you to apply suitable drill stops.
• In case the length of the drills is insufficient, there is the possibility to connect them
to the “Drill Extension” tool. ISO CONNECTION
Contra-angle dental
SURGICAL STANDARDS handpiece
NOTE
• For implants with a length of 18 mm, the corresponding depth 16 mm
markings on drills are not provided such as the suitable drill stops are not
available. It is advisable to prepare the implant site taking into account
14 mm
that the length of the drill, from the tip and up to the retention collar, is
equal to 18.8 mm. It is responsibility of the clinician to evaluate based on
the clinical case, morphology and bone quality, as well as the inclination of 12 mm
the implant, how to prepare the implant site.
• For ISY KONE implants with a diameter of Ø 6 mm, the corresponding
10 mm
screw tap (ref 467HR600 Screw Tap HR Ø6.0mm L36mm Isy Kone) is not
included in the surgical kit (ref. 624NA001). This tool is OPTIONAL and
must be purchased separately if necessary. 8 mm
NOTE
Before the first and each following use, the Reversible Torque Wrench should be dismantled, cleaned, disinfected and sterilized
in accordance with the instructions for use.
To dismantle the torque wrench for cleaning procedure, unscrew the wheel
and then remove the inner bar where the spring is assembled.
2
This is done without removing the Reversible Torque Wrench from the attached
driver in order to avoid additional manipulations and to save time.
3 The grey arrow on the inversion device always indicates in which direction the
force is applied (3). This design was chosen to avoid additional manipulation,
reduce potential sources of error while helping to save time.
Ø3,3 467HR330
Ø3,7 467HR370
Ø4,1 467HR410
Ø4,8 467HR480
Ø4,8 434HS480
Twist drill Ø 3,45 426HR345
Twist drill Ø 3,85 426HR385
Ø6 467HR600
Lance drill 401HR202 ***
IMPLANT
Countersink
Countersink
Screw tap
Screw tap
Screw tap
Screw tap
Screw tap
Screw tap
D1 D2 D1 D2 D1 D2 D1 D2 D1 D2 D1 D2 D1 D2 D1 D2
8mm - -
10mm - -
2,9
12mm 1° ** 1° ** (IR only)
14mm 1° ** 1° **
8mm 1° -
10mm 1° -
3,3
12mm 1° 1° (IR only)
14mm 1° 1°
8mm 1° -
10mm 1° -
12mm 1° 1°
3,7 (IR and
14mm 1° 1° ER)
16mm 2° 1°
18mm 2° 1°
8mm 1° 1°
10mm 2° 1°
12mm 3° 2°
4,1
14mm 3° 2°
16mm 3° 3°
18mm 3° 3°
8mm 1° 1°
10mm 2° 1°
4,8
12mm 3° 2° (only IW)
14mm 3° 2°
8mm 1° 1°
6
10mm 1° 1°
Always 1° 2° 3° 4° 5°
N.B.
The above procedures should be considered indicative; it is responsibility of the clinician to evaluate potential variations of the procedure on the
basis of individual case and bone density.
Due to the presence of cutting edges on drills, it is strongly recommended the use of the stop in order to avoid excessive depth of drilling that
could compromise vital structures.
ADDITIONAL INSTRUMENTS
Optional instrumentation dedicated to the correct management of the surgical procedure.
TAP DRIVERS FOR MANUAL USE COMPATIBLE WITH REVERSIBLE TORQUE WRENCH (JD)
HANDPIECE DRIVER
530HS002 Handpiece Driver HEX0.90 L25mm
HEX DRIVERS FOR MANUAL USE COMPATIBLE WITH REVERSIBLE TORQUE RATCHET (JD)
IMPRESSION TAKING
SCREWDRIVER JD BT GRIP
CAST-ON TECHNIQUE
SCAN ABUTMENT
BT4 BT LINK
246BT1A1 BT Link BT H1mm Ø4.8mm Rotating
247BT1A1 Base BT Link BT H1mm Ø4.8mm no Cap. Rot.
205NA003.05 Castable Plastic Abut. BT Link H1mm Ø5.4mm Kit 5pcs
246BU1A1 BT Link BU H1mm Ø4.1mm Rotating
247BU1A1 Base BT Link BU H1mm Ø4.1mm no Cap. Rot.
205NA001.05 Castable Plastic Abut. BT Link H1mm Ø4.7mm Kit 5pcs
CAST-ON TECHNIQUE
240BT1R0 Base CoCr BT H1.5mm Rotating
240BU1R0 Base CoCr BU H1.5mm Rotating
IMPLANT REPLICA
INTERIM RESTORATIONS
ANGLED ABUTMENT
AESTHETIC ABUTMENTS
BT4 CAPS
BT4 BT LINK
CAST-ON TECHNIQUE
IMPRESSION TAKING
IMPLANT REPLICA
INTERIM RESTORATIONS
ANGLED ABUTMENTS
ESTHETIC ABUTMENTS
BT4 CAPS
690NA066 Retentive Screw BT4 M1.8 Angled abutment IR-EN
BT4 BT LINK
CAST-ON TECHNIQUE
SPHERO® Flex
SPHERO® Block Normo SPHERO® Block Micro
Sphere Ø 2.5mm 0°-7.5°
Sphere Ø 2.5mm Sphere Ø 1.8mm
Divergenza
REF SPECIFICATION REF SPECIFICATION REF SPECIFICATION
254KR1A0 H1mm 255KR1A0 H1mm 256KR1A0 H1mm
254KR2A0 H2mm 255KR2A0 H2mm 256KR2A0 H2mm
254KR3A0 H3mm 255KR3A0 H3mm 256KR3A0 H3mm
KR 254KR4A0 H4mm 255KR4A0 H4mm 256KR4A0 H4mm
254KR5A0 H5mm 255KR5A0 H5mm 256KR5A0 H5mm
254KR6A0 H6mm 255KR6A0 H6mm 256KR6A0 H6mm
254KR7A0 H7mm 255KR7A0 H7mm 256KR7A0 H7mm
254IR1A0 H1mm 255IR1A0 H1mm 256IR1A0 H1mm
254IR2A0 H2mm 255IR2A0 H2mm 256IR2A0 H2mm
254IR3A0 H3mm 255IR3A0 H3mm 256IR3A0 H3mm
IR 254IR4A0 H4mm 255IR4A0 H4mm 256IR4A0 H4mm
254IR5A0 H5mm 255IR5A0 H5mm 256IR5A0 H5mm
254IR6A0 H6mm 255IR6A0 H6mm 256IR6A0 H6mm
254IR7A0 H7mm 255IR7A0 H7mm 256IR7A0 H7mm
254IW1A0 H1mm
254IW2A0 H2mm
255IW1A0 H1mm
254IW3A0 H3mm 256IW1A0 H1mm
255IW2A0 H2mm
IW 254IW4A0 H4mm
255IW3A0 H3mm
256IW2A0 H2mm
254IW5A0 H5mm 256IW3A0 H3mm
255IW4A0 H4mm
254IW6A0 H6mm
254IW7A0 H7mm
254EN1A0 H1.4mm 255EN1A0 H1mm 256EN1A0 H1mm
254EN2A0 H2mm 255EN2A0 H2mm 256EN2A0 H2mm
254EN3A0 H3mm 255EN3A0 H3mm 256EN3A0 H3mm
EN 254EN4A0 H4mm 255EN4A0 H4mm 256EN4A0 H4mm
254EN5A0 H5mm 255EN5A0 H5mm 256EN5A0 H5mm
254EN6A0 H6mm 255EN6A0 H6mm 256EN6A0 H6mm
254EN7A0 H7mm 255EN7A0 H7mm 256EN7A0 H7mm
254ER1A0 H1mm 255ER1A0 H1mm 256ER1A0 H1mm
254ER2A0 H2mm 255ER2A0 H2mm 256ER2A0 H2mm
254ER3A0 H3mm 255ER3A0 H3mm 256ER3A0 H3mm
ER 254ER4A0 H4mm 255ER4A0 H4mm 256ER4A0 H4mm
254ER5A0 H5mm 255ER5A0 H5mm 256ER5A0 H5mm
254ER6A0 H6mm 255ER6A0 H6mm 256ER6A0 H6mm
254ER7A0 H7mm 255ER7A0 H7mm 256ER7A0 H7mm
Accessori Sphero®
PICTURE REF PRODUCT NAME SPECIFICATION
NOTA Every SPHERO® as listed above includes the following products: 1pc. Titanium Abutment with self-aligning 2.5mm or 1.8 mm sphere, 2pcs. Soft
Retention Pink Caps, 1pc. Stainless Steel Housing, 1pc. Protective Disk and 3 pcs. Directional Rings.
These Devices are produced by Rhein83. s.r.l. Via E. Zago, 10/ABC, 40128 Bologna Italy.
Abutment Connector
KR IR ER
REF SPECIFICATION REF SPECIFICATION REF SPECIFICATION
261KR1A0 H1mm
261KR2A0 H2mm 261IR1A0 H1mm 261ER1A0 H1mm
261KR3A0 H3mm 261IR2A0 H2mm 261ER2A0 H2mm
261KR4A0 H4mm 261IR3A0 H3mm 261ER3A0 H3mm
261KR5A0 H5mm 261IR4A0 H4mm 261ER4A0 H4mm
261KR6A0 H6mm
Locator® Accessories
PICTURE REF PRODUCT NAME SPECIFICATION
530JD029 Screwdriver JD Locator L10mm (for reversible torque wrench JD)
690NA006.04 Replacement Males Locator® 15N Blue Kit 4pcs (700gr. 0-20°)
690NA008.04 Replacement Males Locator® 30N Pink Kit 4pcs (1400gr. 0-20°)
690NA010.04 Replacement Males Locator® 50N Neutral Kit 4pcs (2300gr. 0-20°)
690NA005.04 Replacement Males Locator® 10N Red Kit 4pcs (700gr. 20-40°)
690NA007.04 Replacement Males Locator® 20N Orange Kit 4pcs (900gr. 20-40°)
690NA009.04 Replacement Males Locator® 40N Green Kit 4pcs (1400gr. 20-40°)
MATERIAL
SPECIFICATIONS
TITANIUM GRADE 4 IMPLANTS
COMPOSITION:
Gold (Au) 60.0 %
Platinum (Pt) 24.9 %
Palladium (Pd) 15.0 %
Iridium (Ir) 0.1 %
PHYSICAL PROPERTIES:
Melting Range 1450 – 1500 °C
Coefficient of Expansion (CTE) 25-500°C – 25-600°C: 12.3•10-6 °C-1
The temporary abutments in PEEK and the SCAN ABUTMENT are made of PEEK / TECAPEEK CLASSIC (chemical name
Polietereterketone). This material is suitable to stay in contact with tissue for up to 180 days.
Depending on the intended use, the Biotec instrumental is made of specific types of stainless steel.
SYMBOLS USED
ON LABELS
0426
Number of the notification body Do not reuse
0426
Catalogue number
Lot/batch number
RESPONSABILITY GUARANTEE
The use of BTK medical devices is reserved exclusively for personnel We constantly guarantee that the quality of our products and
with the necessary qualifications for the exercise. An improper or services meets the high expectations of our customers and their
incorrect use of the devices can cause the failure or worse, injury patients. Specialized professionals are committed to offering
to the patient or the user. BTK implant systems should only be used complete solutions in applied research, engineering, training and
with original BTK components and instruments and in accordance related activities. Biotec is available to customers in the event that
with the specific BTK instructions. Combining with different devices a defect in the product or its use is found.
may cause a failure. Biotec must not and can not control the
procedures for using the product for implant-prosthetic treatment. VALIDITY
Therefore, Biotec assumes no responsibility for the application of
the device and its processing nor for any incongruous use of the The contents are updated at the date of publication. This manual
device under the surgical or prosthetic profile, nor in any case for replaces all previous editions.
failure, adverse reactions or damage to the patient or dentist as a
result of application of the product. CASE DOCUMENTATION AND TRACEABILITY
BTK absolutely recommends documenting implant cases
STERILITY OF WARRANTY AND DISPOSABLE comprehensively at the clinical, radiographic, photographic and
Dental implants are supplied STERILE (gamma ray sterilization). statistical levels. The clinician must guarantee the traceability of the
The sterility of the medical implant is guaranteed only according to devices used. It is advisable to use the adhesive labels included in
the following conditions: the expiry date stated on the packaging is the packaging of the BTK devices, which show the code and lot of
still valid; there is a red dot on the sterile vial which demonstrates the device used, for the purpose of documentation on the medical
that it has undergone gamma ray irradiation; the sealed package records and on the relative implant passport of the patient.
has not been opened and does not show any signs of damage.
Compliance with all these conditions must be ensured; alternatively
do not use the device.
TRAINING
Comprehensive and regular training ensures long-term implant
Surgical components, laboratory accessories and instruments are success.
not supplied in sterile packs, therefore before use they must be Be advised that we strongly recommend regular education events
properly CLEANED and STERILIZED, as shown in the instructions for in order to update your know-how and clinical expertise.
use. Biotec dental implants, prosthetics and laboratory accessories
are designed for SINGLE USE. In fact, reuse is a potential risk DELIVERY TERMS
and could damage the construction of the device, making it
inappropriate for its intended use. Biotec explicitly declares the BTK delivery terms are 1 working day for order received before
single-use of MD and assumes no responsibility for any re-use by 12.00 p.m. of the previous day in Italy; except for islands where
delivery is evaluated to be 2 working days. For export deliveries
users.
contact Biotec offices.
STORAGE
QUALITY STANDARD
Biotec products must be stored at room temperature and protected
from direct heat or sunlight and dust. Owing to extensive research, development and to a strict quality
standard, we guarantee premium quality materials and products.
Our products meet the requirements of directive 93/42 /EEC and
INSTRUCTIONS FOR USE subsequent amendments and additions, and therefore have the CE
The information in this manual is not intended to be exhaustive mark, in accordance with the corresponding law. BTK has a quality
for BTK implant systems. It is recommended that new customers system certified UNI EN ISO 9001 and UNI EN ISO 13485.
follow the training courses that Biotec makes available with trained
personnel and clinicians who are experts in implantology and in the
use of BTK devices. The complete and updated user manuals, which CAUTION
allow the correct use of the product, are available online (www.btk. In addition to the instructions for use, warnings and risks reported
dental) or at BTK and / or the local distributor. both in this document and in the instructions for use, it must always
be ensured that the devices used in the oral cavity are not aspirated
or swallowed by the patient.
AVAILABILITY
Not all products described here are available in ExtraEU countries.
For more information, please contact BTK and / or your local COPYRIGHT AND TRADEMARKS
distributor. BTK documents cannot be reprinted or published, in whole or in
part, without the written permission of BTK.
RETURNS BTK, BIOTEC, The Smile System® or Implanting Trust, Smile Again®
are trademarks or registered trademarks of BIOTEC s.r.l. and / or
Biotec does not accept returned goods if the packaging seals are its affiliates.
broken or not conforming to the sale specifications of the company.
CERTIFIED
QUALITY SYSTEM
BIOTEC is certified UNI EN ISO 9001
and UNI EN ISO 13485.
MADE IN ITALY
USED GLOBALLY
Biotec srl reserves the right to make changes, corrections and / or improvements to the document without notice. The content is updated at the date of publication.
We constantly ensure that the quality of our products
and services meet the high expectations of our customers
and their patients.
Specialized professionals are taking care to offer
It is customer’s responsibility to check the latest update available, by contacting Biotec or visiting the website www.btk.dental.
comprehensive solutions in applied research, engineering,
education and related activities.
ALL IMAGES ARE FOR ILLUSTRATIVE PURPOSE. The informations may contain typographical imprecisions.
REF. 06200119 Rev 4 - 21.09.2020