Qualia® NeoActive Update 1
Qualia® NeoActive Update 1
Qualia® NeoActive Update 1
1
Index
Our Company 00
Catalogue Consultation 00
Qualia®NeoActive Conical Implant
Feature 00
Qualia®NeoActive No Mount 00
Features and References 00
Osseoactive® Surface Treatment 00
Surgical protocol 00
Cleaning, disinfection and sterilisation 00
Direct to Implant Restorations 00
Surgical Instruments
Prosthetic Instruments
Bibliography 00
General sales conditions 00
Maximum resistance
Elastic limit
720*
483
100
600
200
300
400
500
700
800
900
0
Tension [MPa]
our suppliers to make sure that we continue to meet the needs of our customers. manufacturer’s licence for medical devices and the
commercial authori-sation by the AEMPS 6425-PS
True to our entrepreneurial spirit, we continue to seek new solutions and products (Spanish Agency for Medicines and Medical Devices).
that meet the new demands of the sector. Therefore, we entered in agreement with Our quality management system is certified according to
BIOSTAR® Laboratorios, SLU a Spanish manufacture for the exclusive production the requirements of the UNE-EN-ISO 9001:2015 and
and manufacture of Qualia®NeoActive implants made of premium high strength UNE-EN-ISO 13485:2016 standards, also complying
materials of high quality and biocompatible . with the requirements of GMP 21 CFR 820.
Like our motto goes “were quality meets service”, our promise to our customers is
to continue improvement and sourcing out the best quality products available, at
reasonable cost combining with best service that goes beyond the sale.
*
Product
Image
Implant Analog 3D Implant Analog
44 4
4|
Conical connection implants
Features
CONNECTION
» Conical connection: 11° morse taper with double internal
hexagon
» Conical sealing: no infiltration
» Friction fit: no micro-movements
» RP single platform for all diameters
» Platform switch: soft tissue formation and emergence profile
shaping
11° conical connection
CORTICAL AREA with double internal
» Micro-thread design: preserves marginal bone, reduces hexagon
cortical stress and improves load distributions
» Inverted cone cortical macro-design: no cortical Variable angle
compression (except for 3,40mm diameter implant) double thread
BODY
Active apex
» Double lead thread: quick insertion to reduce surgical time
» Grooved canal threads and plateau: releases bone
stress and enables fluid flow
» Variable geometry thread: provides high primary stability:
» Coronal - thick trapezoidal thread
Core
» Medium - thinner trapezoidal thread Size
» Apical - V-shaped thread
» Optimized morphology
» Apical oblique vents: collect bone detritus during the
insertion and facilitates a change of insertion axis
» Active apex (self-tapping): makes the implant insertion
easy with undersized drilling technique
» Atraumatic apex: protects anatomical structures
CONICAL DESIGN
» Facilitates bone shaping at low density
» Indicated for immediate loading
» Indicated for immediate post-exodontic placement
» Indicated for apical collapse situations
RP ( Ǿ3,50 mm) RP ( Ǿ4,00 mm)
8 10 11.5 13 16 8 10 11.5 13 16
6 8 10 11.5 13 16 6 8 10 11.5 13 16
Usage recommendations
All implant planning must respect the natural biomechanical stability Odontogram
of the oral cavity and allow the natural emergence of the dental crown,
through the soft tissue, by means of an implant with a pros-thetic
platform whose diameter is proportionally smaller than the
emergence diameter of the tooth to be restored. The implantologist
must assess the quantity and quality of bone in the recipient area of
the implant and consider the need for prior or simultaneous bone re-
Implant diameter
generation as appropriate. A RP B RP C RP D RP
Qualia®NeoActive has a broad range of implants to cover every Ø3,50mm Ø4,00mm Ø4,50mm Ø5,00mm
restoration possibility.
In the odontogram, the inverted trapezoids identified with letters rep-
Coronal implant diameter
resent the diameters and platforms of the implants recommended for RP
Ø2,85mm
these dental positions. These recommendations apply to teeth re-
placement with single restoration, bridges and partial or total implant-
retained tissue-supported prosthesis.
Remember to maintain minimum distances between adjacent
implants and/or implants and teeth, to preserve papillae, bone
vascularization and natural emergence profiles.
The choice of the appropriate implant, in each case, is the exclusive
responsibility of the clinician. Qualia®NeoActive Medical
recommends taking into account warnings based on scientific
evidence contained in product catalogues and website.
ber, product manufacturer, expiration date and product Description of the symbology used
identi-fication symbols. MDD CE certification and notified body Do not resterilise
Note. Do not open the sterile container until the time of implant placement. Name of the medical device Do not use if the packaging is damaged
Implant view
Qualia®NeoActive No Mount implant has the advantage of avoiding upper washer
its handling to disassemble the Mount, removing the occasional
difficulty of access to the location with reduced mouth opening or
suppressing the risk of primary stability reduction due to over-
instrumentation.
The plastic vial holds the implant vertically between a lower titanium
plate and an upper washer also made of titanium, providing stability
*
Implant view
without movement, while avoiding contact. between plate and washer No Mount
* Cover screw:
In Qualia®NeoActive No Mount option,
cover screws are supplied separately.
Refer to the references in the table
below
IMPLANT PLATFORM
Ǿ (mm) Ǿ Core (mm) Length Reference Type Ǿ (mm) Internal Metric
8 mm AC3580 Length ( L ) Reference
10 mm AC3510
3.5 11.5 mm AC3511 5.10mm
13 mm AC3513
16 mm AC3516
8 mm AC4080
10 mm AC4010
4.0 11.5 mm AC4011
13 mm AC4013
16 mm AC4016
6 mm AC4560
RP 2.85 M 1,60
8 mm AC4580
10 mm AC4510
4.5
11.5 mm AC4511
13 mm AC4513
16 mm AC4516
6 mm AC5060
8 mm AC5080
10 mm AC5010
5.0
11.5 mm AC5011
13 mm AC5013
16 mm AC5016
Osseoactive®
Surface treatment
Osseoactive® surface, textured by subtraction using sandblasting Osseoactive® has a thicker TIO2 layer than most current
with white corundum and double etching of hydrofluoric acid and a surfaces.
combination of sulphuric and phosphoric acid, creates a macro and O (% At) C (% At) Ti (% At) N (% At) Si (% At) Ca (% At)
Layer thickness
TIO2 (Nm)
mi-cro porosity with optimum average values whose key
Osseoactive® 43.9 34.9 18.0 0.6 0.5 0.5 16-25
characteristics for achieving a correct and rapid osseointegration
Plasma Spray 45.5 38.9 14.2 1.4 -- -- 5.5
which gives it reli-ability and predictability.
Mechanised 39.7 36.9 20.1 1.1 1.7 0.2 5.7
Sandblasting
Main features: 51.4 34.9 14.5 1.3 Traces -- 5.7
and Etching A.
Double acid
• Pure TIO2 surface etching
36.2 53.7 6.8 5.4 3.3 -- Not available
Note. For more information on surface treatment, see the bibliography at the end of this catalogue.
OSPD20G OSTD25G OSTD33G OSTD37G
RP 4,00 MM
RP 4,50 MM CORTICAL
RP 5,00 MM
11
GTAP 40M GTAP 45M GTAP 50M
RP 3,50 MM
RP 4,00 MM Ǿ4.00 mm
RP 4,50 MM CORTIC Ǿ4.50 mm
AL
RP 5,00 MM CORTIC Ǿ5.00 mm
AL
Ǿ3.50 mm
RP 4,00 MM Ǿ4.00 mm
RP 4,50 MM Ǿ4.50 mm
Ǿ5.00 mm
RP 5,00 MM
12
Direct-to-implant
restorations
CONICAL CONNECTION PLATFORMS
HEX NON-HEX
14
Base Abutment +Castable Abutment
HEX NON-HEX
UCLA
Straight Abutment
15
HEX NON-HEX
HEX NON-HEX
Ti Base
16
HEX NON - HEX
17
Dynamic Ti Base
Multi Unit Abutment Angled 30D Impression Transfer Multi Unit Abutment
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Healing Multi Unit Abutment Cylinder Multi Unit Abutment
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SURGICAL INSTRUMENTS
Surgical Drills
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Abutment Extractor Screw
Depth Gauge/Parelleling Pins Extractor Screw
TAPS RATCHETS
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Length ( L ) Reference Length ( L ) Reference
2.80 mm/Mini 20.00 mm/Short
9.50 mm/Short 25.00 mm/Long
14.50 mm/Long
27.00 mm/Extra Long
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PROSTHETIC
INSTRUMENTS
Length ( L ) Reference
Length ( L ) Reference
13.40 mm/Short
12.00 mm/Short
19.40 mm/Long 18.00 mm/Long
Screwdriver Tip. CA
Length ( L ) Reference
20.00 mm/Short
25.00 mm/Long
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General recommendations
Treatment Planning
Personal
Clinical X-Ray Psychological Informed Patient Surgical Surgical Implant
Lab Test and instrument Suture
evaluation Test analisys Consent preparation preparation Incision drill placement
14,5 mm
13 mm Surgical drills should be inserted in the Each instrument Damaged instruments The clinician must keep
contra-angle with the surgical motor stopped, must be used only must be disposed in the patient's file the
11,5 mm ensuring correct anchoring and rotation before for the specific use according to the identification label supplied
10 mm starting drilling. Treat the drills with great care: recommended by regulations established with the product, for proper
the slightest damage to the tips can compromise the manufacturer. by the manufacturer. traceability.
8,5 mm their effectiveness.
IMPORTANT WARNINGS
About implant placement Maximum insertion torque and speed Qualia®NeoActive implants
Excessive compression to the bone can The recommended insertion torque is Qualia®NeoActive surgical protocol establishes
lead a non-osseointegration of the implant. between 35 and 50 Ncm according to each a crestal position of the implant platform.
case without being limited to a single torque [1], [2]
Failure to follow the steps described in To avoid cortical stress and deformation of the
the surgical sequence may result in: The Implant placement should be performed with controlled key and/or connection of the implant, insertion
· Lack of primary stability due to loss of torque and according to the density and bone. with contra-angle (CA) must respect the
support bone. maximum recommended rpm (25 Rpm) and
Insertion instruments or contra-angle (CA)
· Difficulties during the implant placement. the maximum indicated torque (50 Ncm).
screwdrivers use maximum speed of:
Exceeding the torque (50 Ncm) at the If the implant is not fully inserted using the
implant insertion can produce: You can consult the bibliography at the end of this catalogue. maximum recommended torque, the implant
· Irreversible distortions in the must be removed and the drilling repeated, then
internal/external connection. the insertion must be performed.
· Irreversible deformations in the
instruments indicated for insertion of Check the final insertion torque with the regulable
the implant. torque wrench Ref. TORK70 or with CA.
· Difficulty of disassembling the
instrument/implant assembly Make sure that the entire implant with
Osseoactive®surface treatment is completely covered
with bone.
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Surgical drills
Tapered drills:
The Qualia®NeoActive surgical drill length measuring system is simple
and intuitive and allows you to guide you through the surgical site Laser marking on the drills rod identifies its largest and smallest
drilling process. It is recommended for use with irrigation and is made diameter and length. The drills have conical geometries adapted to
of stainless steel with a maximum use limit of 45. It is important to note
the size of each implant, both in diameter and length. That it's
the length of the end drill tip, because it is NOT INCLUDED in the length
means, every diameter and length of implant has a final drill. They
measurements of the end drill..
are used in conical body implants.
Millimeter drills:
Stepped drills:
Laser marking on the drills rod identifies their diameter, and the band
The stepped geometry of the drills has been specially designed for
horizontal laser marking in its active part represents the different
the tapered core or reduced apical diameter implants. The laser
lengths of the implants. They are used in straight or cylindrical body
marking on the drill rod identifies its diameter and the horizontal
implants.
band of the laser marking. The active area represents the different
lengths of the implants.
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Instructions for cleaning and disinfection
of: instruments and boxes (surgical and
prosthetic)
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Bibliography
Surface treatment
• Surface roughness alters osteoblast proliferation, differentiation • Highest degree of bone-implant bonding on a sandblasted
and matrix production in vitro. And participates in the surface and acid etching than others.
determination of phenotypic expression of cells in vivo. Martin Buser D, Schenk RK, Steinemann S, Fiorellini JP, Fox CH, Stich H.
JY1, Schwartz Z, Hummert TW, Schraub DM, Simpson J, Lankford J Influence of surface char-acteristics on bone integration of titanium
osseo-integration.
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the shorter healing times of the placement of implants for the
• Among the most desirable characteristics of an implant are those
restoration. This article presents a discussion of the surface
that ensure that the implant-tissue interface will be established
characteristics and the design of the implants, which should allow
quickly and can be maintained.
the clinician to better understand osseo-integration and the
Gupta A, Dhanraj M, Sivagami G. Status of surface treatment in
information coming from implant manufacturers, which allows a
endosseous implant: a literary overview. Indian J Dent Res.
better selection of the implant.
2010;21(3):433-8.
Ogle OE. Implant surface material, design, and osseo-integration.
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Implant size choice
• The wide platform provides increased mechanical strength of
• When it comes to severe atrophy of the jaws, short and wide
the connection being im-portant for mechanical stability (the
implants can be placed suc-cessfully (28 included studies,
results of a 3-year prospective multi-centred clini-cal trial and
between 1991 and 2011).
the results at 1 year from a multi-centre 2 retrospective clinical
Karthikeyan I, Desai SR, Singh R. Short implants: a systematic
study. Wide diameter implants for molar replacement).
review. J Indian Soc Peri-odontol. 2012;16(3):302-312.
Polizzi G, Rangert B, Lekholm U, Gualini F, Lindstrom H.
• Survival of the implants (short <10 mm) is improved with longer Brånemark System Wide Platform implants for single molar
length, placement of the mandible with respect to the maxilla, and replacement: clinical evaluation of prospective and retrospec-tive
in non-smokers (a systematic review of the prognosis of short materials. Clin Implant Dent Relat Res. 2000;2(2):61-69.
• Among the risk factors examined, most failures of short implants Vigolo P, Givani A, Majzoub Z, Cordioli G. Clinical evaluation of
can be attributed to poor bone quality in the maxilla and surface small-diameter implants in single-tooth and multiple-implant
treatment (35 studies in humans met the criteria.) The studies restorations: a 7-year retrospective study. Int J Oral Maxillofac
included 14,722 Implants, failure rates of implants with lengths of Implants. 2004;19(5):703-709.
implants with an oxidized sur-face to restore posterior teeth: 1 to 3- 98.9% at 5 years and 97.8% at 10 years. For complete upper set on
year results of a prospective study. Int J Oral Maxil-lofac Implants. 4 to 6 implants, survival rates were 97.9% at 5 years and 95.9% at
2011;26(2):393-403. 10 years (from 210 articles were selected 51).
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Morse taper connection
• Implant systems with Morse Taper connection provide better
• Among the risk factors examined, most failures of short
results in terms of abutment fit, connection stability and
implants can be attributed to poor bone quality in the maxilla
antibacterial seal performance.
and surface treatment (35 studies in humans met the criteria.)
Schmitt CM1, Nogueira-Filho G, Tenenbaum HC, Lai JY, Brito C, Döring
The studies included 14.722 Implants, failure rates of implants
H, Nonhoff J. Perfor-mance of conical abutment (Morse Taper)
with lengths of 8,5 and 9, were 3,2%, and 0,6% respectively).
Survival rate of the one-piece implant: 96.79% after 5 years. connection implants: a systematic review. J Biomed Mater Res A. 2014
Magini RS1, López-López J4, Souza JC3. Morse taper dental implants
and platform switching: The new paradigm in oral implantology. Eur J • The characteristics of the implant-abutment joint could be a
• The internal connection of Morse Taper is more effective in relation Scarano A1, Mortellaro C, Mavriqi L, Pecci R, Valbonetti L.
to biological aspects, allowing less bone loss and bacterial Evaluation of Microgap With Three-Dimensional X-Ray
filtration in individual implants, including aesthetic regions. In Microtomography: Internal Hexagon Versus Cone Morse. J
addition, this type of connection can be successfully indicated for Craniofac Surg. 2016 May;27(3):682-5. doi:
Goiato MC1, Pellizzer EP, da Silva EV, Bonatto Lda R, dos Santos
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Radiographic templates
• For the choice of the size during the surgical planning, in those cases that is only available the diagnostic image in Orthopantomography format
(OPG), there are available transparent acetate overlay, such as radio logical templates, different for each QUALIA®NEOACTIVE ® implants family
morphology, with the figures of the implants in scales 1:1,00 and 1:1,25 that are superimposed over OPG for thought comparison and measurement,
to help to the choice of adequate diameter and length. The extensions of the templates correspond to magnifications of the most of OPG that are
detailed. . QUALIA®NEOACTIVE ® recommend the planning of the treatment with dental implants based on Cone-Bean Computed
Tomography: CBCT
• Literature support the use of CBCT in dental implants treatment • In difficult cases with alveolar lateral deficient bone, the
planning, especially in what means to lineal measures, diagram of the increase could be evaluated better from CBCT
tridimensional evaluation of the alveolar topography, proximity to to avoid sub-estimation , that appears more often when is
vital anatomical structures and manufacturing of surgical guides. based just in panoramic radiographies.
Benavides E1, Rios HF, Ganz SD, An CH, Resnik R, Reardon GT, Dagassan-Berndt DC1, Zitzmann NU2, Walter C2, Schulze RK3.
Feldman SJ, Mah JK, Hatcher D, Kim MJ, Sohn DS, Palti A, Perel Implant treatment plan-ning regarding augmentation procedures:
ML, Judy KW, Misch CE, Wang HL. Use of cone beam computed panoramic radiographs vs. cone beam com-puted tomography
tomography in implant dentistry: the International Congress of Oral images. Clin Oral Implants Res. 2016 Aug;27(8):1010-6. doi:
Implantologists consensus report. Implant Dent. 2012 Apr;21(2):78- 10.1111/ clr.12666. Epub 2015 Jul 30.
• Pre operatory planning with CBCT implants allowed planning of the evaluation of every dental im-plant places and CBCT is the method
treatment with a high grade of prediction and concordance in of the image selection for obtaining this information . Tyndall DA1,
comparison with surgical standard, based on panoramic Price JB, Tetradis S, Ganz SD, Hildebolt C, Scarfe WC; American
radiography, which the prediction of the implant was deficient with. Academy of Oral and Maxillofacial Radiology. Position statement of the
Guerrero ME1, Noriega J2, Jacobs R3. Preoperative implant planning American Academy of Oral and Maxillofacial Radiology on selection
considering alveolar bone grafting needs and complication prediction criteria for the use of radiology in dental implan-tology with emphasis on
using panoramic versus CBCT images. Imaging Sci Dent. 2014 cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral
Sep;44(3):213-20. doi: 10.5624/isd.2014.44.3.213. Epub 2014 Sep 17. Radiol. 2012 Jun;113(6):817-26. doi: 10.1016/j.oooo.2012.03.005.
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Use of the interface in zirconium restorations
Scientific evidence to recommend the use of the interface in zirconium restorations:
The maximum load capacity of a crown or framework made with a titanium plus zirconium interface is significantly higher [1] than
when the crown or framework is made entirely of zirconium directly connected to the implant. The use of an intermediate metal
component has a beneficial influence on the stability of the zirconium oxide abutments. [2] The failure mode in zirconium
restorations depends on the support material and its design. [3] In zirconium restorations with intermediate abutment, initially only
partial deformation of the components occurs and cracks occur prior to some fractures of the zirconium abutment. [4] The
dimension of the interface (connector) on which to cement the zirconium prosthesis is clinically relevant. [5] The Interface reduces
• [1] Kim JS1, Raigrodski AJ, Flinn BD, Rubenstein JE, Chung KH, • [5] Larsson C1. Zirconium dioxide based dental restorations.
Mancl LA. In vitro assess-ment of three types of zirconia implant Studies on clinical performance and fracture behaviour. Swed
abutments under static load. J Prosthet Dent. 2013 Apr;109(4):255- Dent J Suppl. 2011;(213):9-84.
• [2] Truninger TC1, Stawarczyk B, Leutert CR, Sailer TR, Hämmerle Wear at the titanium-tita-nium and the titanium-zirconia implant-
CH, Sailer I. Bending mo-ments of zirconia and titanium abutments abutment e: a comparative in vitro study. Dent Mater. 2012
with internal and external implant-abutment con-nections after Dec;28(12):1215-20. doi: 10.1016/j.dental.2012.08.008. Epub 2012
aging and chewing simulation. Clin Oral Implants Res. 2012 Sep 27.
Jan;23(1):12-8. doi: 10.1111/j.1600-0501.2010.02141.x. Epub
2011 Mar 28. • [7] Klotz MW1, Taylor TD, Goldberg AJ. Wear at the titanium-
3913(13)60306-6.
supporting all-ceramic crowns after aging. Clin Oral Implants Res. 2014
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General sales conditions
Consult the general sales conditions updated in our web www.qualiaimplants.com
All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means,
electronic or mechanical, in photocopies, on recordings, or in any other manner not provided herein without prior
written permission of the owner of the trademark rights, edition and printing. Qualia®NeoActive is a registered
trademark of Qualia® Experiences.
Important
• For the latest version of our catalogues, please visit our website at www.qualiaimplants.co
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