(211 days)
No
The summary describes a CAD/CAM process for designing and milling dental abutments, which is a standard digital manufacturing technique and does not inherently involve AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device provides support for dental prosthetic restorations but does not directly treat a disease or condition for therapeutic purposes.
No
Explanation: The device description and intended use clearly state that this product, BioHorizons CAD/CAM Abutments, are dental abutments designed to provide structural support for dental prosthetic restorations. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states that the device is a physical dental abutment made of titanium alloy, which is a hardware component. While CAD/CAM techniques are mentioned for design, the device itself is a physical implant component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental abutment placed onto a dental implant to provide support for dental prosthetic restorations. This is a mechanical function within the body.
- Device Description: The description details the physical characteristics, materials, and purpose of the abutment as a component for dental restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural component for dental prosthetics.
N/A
Intended Use / Indications for Use
BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Dynamic mechanical fatigue testing was performed in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. Results of the testing demonstrate that the fully milled, worst-case 30° angled configurations of both the 3.0mm and 3.5mm prosthetic platform abutments and the titanium bases with bonded zirconia superstructure perform in accordance with their intended use.
Compatibility testing was performed on a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants. The subset included the following Zimmer® item numbers: TSV4B8, TSV4B10, TSVWH10, TSVWB10, TSVWB11, TSVWH11, TSVT6B10, TSV6H11, TSV6H13 and TSV6H16. This testing verifies compatibility of BioHorizons Abutments for Zimmer® with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items based on equivalent mating platform geometry.
Steam sterilization validation testing was performed new in accordance with AAMI/ANSVISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. Test results demonstrate a sterility assurance level (SAL) of 10°.
Finally, software intended use validation testing of the software systems utilized in the manufacture of the CAD/CAM abutments was performed to ensure that the program design limitations prevent the user from milling abutments that do not fulfill the BioHorizons design criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111935, K103691, K121787, K073268, K071638, K143022, K013227
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
BioHorizons Implant Systems, Inc. Mr. Michael Davis Director, Regulatory Affairs 2300 Riverchase Center Birmingham, Alabama 35244
Re: K151621
Trade/Device Name: BioHorizons CAD/CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 11, 2015 Received: December 14, 2015
Dear Mr. Davis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement (as required by ODE for all 510(k)s received after January 1, 1996)
510(k) Number: K151621
Device Name: BioHorizons CAD/CAM Abutments
Indications for Use:
BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
3
510(k) Summary 21 CFR 807.92
Submitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham, AL 35244
Phone (205) 967-7880
Fax (205) 870-0304 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official contact: | Michael Davis, Director, Regulatory Affair |
| Date prepared: | January 13, 2016 |
Name of the Device
Trade Name: | BioHorizons CAD/CAM Abutments |
---|---|
Common or Usual Name: | Dental implant abutment |
Classification Name: | Endosseous dental implant abutment |
Classification Number: | Class II (21 CFR 872.3630) NHA |
Predicate Devices
Primary Predicate Device:
-
- K122295, Core 3D Abutment System for Digital Prosthetic Solutions, October 24, 2013.
Reference Predicate Devices:
- K122295, Core 3D Abutment System for Digital Prosthetic Solutions, October 24, 2013.
-
- K111935, NT-Trading Ti-Base Abutment, 2-CONnect Abutment, February 17, 2012.
-
- K103691, BioHorizons Abutments for Zimmer, November 3, 2011.
-
- K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012.
-
- K073268, BioHorizons Internal Implant System, February 8, 2008.
-
- K071638, BioHorizons Tapered Internal Implant System, October 10, 2007.
-
- K143022, BioHorizons Tapered Internal Implant System, January 8, 2015.
-
- K013227, Zimmer® Dental (formerly Sulzer Dental) Screw-Vent® and Tapered Screw-Vent® Systems, November 19, 2001.
Device Description
BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.
Indications for Use
BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment
4
blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.
Technological Characteristics
The fundamental scientific technology of the BioHorizons CAD/CAM Abutments that are the subject of this 510(k) is substantially equivalent to the existing abutments of the referenced predicate devices. (Refer to the following Summary Table of Substantial Equivalence for comparison of the subject device to the declared predicate devices.) Select abutment models are further processed by applying Laser-Lok to a specified region of the abutment margin.
Both the subject device and predicate devices include similar design features such as abutment base material, surface treatment, implant-abutment connection tailored to the implant system(s) with which the devices are intended to be used, anti-rotational geometry, prosthetic platform sizes and mode of retention which thereby demonstrates substantial equivalence in their respective designs. Any specific differences related to prosthetic platform sizes between the subject device and the predicate devices do not raise questions of safety or effectiveness based on the performance testing conducted on the worst-case manufactured dimensions which supports the determination that the subject devices are appropriate for their intended use and do not render the devices not substantially equivalent. The features, similarities and differences are further summarized in tabular format in Table 1. Summary Table of Substantial Equivalence following in this section. The Zimmer compatible platforms are identical to the declared predicate, K103691. The BioHorizons 3.0mm platform compatible implant is identical to the declared predicate device cleared in K143022. The compatible platform implants are substantially equivalent to the declared predicates.
All materials, suppliers and packaging methods remain the same as those utilized for the predicate BioHorizons Abutments for Zimmer (K103691). Additionally, the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Abutments for Zimmer (K103691). The BioHorizons CAD/CAM Abutments are substantially equivalent to the features of the predicate abutment devices which could affect safety or effectiveness because of the similarities in design, materials and intended use.
Abutment Manufacturing
A custom abutment design file is created by the customer using a 3Shape abutment library. The abutment design file is converted to a stereolithography (.stl) file using 3Shape software. The .stl file is converted to a numerical control (.nc) file using an appropriate software application (e.g.
5
SUM3D). After the custom abutment design is uploaded, the milling machine software executes the necessary commands to mill the final abutment. The digitally designed file is to be sent to a registered and listed BioHorizons contract manufacturer for milling. BioHorizons CAD/CAM Abutments are compatible with commercially available dental CAD/CAM systems, such as 3Shape.
Summary of Testing
Dynamic mechanical fatigue testing was performed in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. Results of the testing demonstrate that the fully milled, worst-case 30° angled configurations of both the 3.0mm and 3.5mm prosthetic platform abutments and the titanium bases with bonded zirconia superstructure perform in accordance with their intended use.
Compatibility testing was performed on a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants. The subset included the following Zimmer® item numbers: TSV4B8, TSV4B10, TSVWH10, TSVWB10, TSVWB11, TSVWH11, TSVT6B10, TSV6H11, TSV6H13 and TSV6H16. This testing verifies compatibility of BioHorizons Abutments for Zimmer® with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items based on equivalent mating platform geometry.
Steam sterilization validation testing was performed new in accordance with AAMI/ANSVISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. Test results demonstrate a sterility assurance level (SAL) of 10°.
Finally, software intended use validation testing of the software systems utilized in the manufacture of the CAD/CAM abutments was performed to ensure that the program design limitations prevent the user from milling abutments that do not fulfill the BioHorizons design criteria.
Conclusion
The data presented in this submission demonstrates that the proposed devices are substantially equivalent with respect to performance and intended use. The proposed devices perform as well as the legally marketed predicate devices. Furthermore, the proposed devices do not pose any new or increased risks as compared to the legally marketed predicate devices.
6
Table 1. Summary Table of Substantial Equivalence
Subject Device | Primary Predicate Device | Reference Predicate Devices | Compatible Implant Devices | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
BioHorizons Implant Systems, | |||||||||||
Inc. | |||||||||||
BioHorizons CAD/CAM | |||||||||||
Abutments | Core 3D Abutment System for | ||||||||||
Digital Prosthetic Solutions | |||||||||||
K122295 | NT-Trading Ti-Base Abutment, 2- | ||||||||||
CONnect Abutment | |||||||||||
K111935 | BioHorizons Implant Systems, | ||||||||||
Inc. | |||||||||||
BioHorizons Abutments for | |||||||||||
Zimmer K103691 | Subject Device | BioHorizons Implant Systems, Inc. | |||||||||
BioHorizons CAD/CAM | |||||||||||
Abutments | BioHorizons Implant Systems, Inc. | ||||||||||
Tapered Internal Plus Implants | |||||||||||
K121787 | BioHorizons Implant Systems, Inc. | ||||||||||
Internal Implant System | |||||||||||
K073268 | BioHorizons Implant Systems, Inc. | ||||||||||
Tapered Internal Implant System | |||||||||||
K071638 & K143022 | Zimmer® Dental (formerly | ||||||||||
Sulzer Dental) Screw-Vent® and | |||||||||||
Tapered Screw-Vent® Systems | |||||||||||
K013227 | |||||||||||
Classification/ | |||||||||||
Product Code | 872.3630/NHA | 872.3630/NHA | 872.3630/NHA | 872.3630/NHA | Design | ||||||
Intended Use | BioHorizons CAD/CAM Abutments are | ||||||||||
dental abutments placed onto a dental | |||||||||||
implant to provide support for dental | |||||||||||
prosthetic restorations. The abutments | |||||||||||
include: 1) Titanium abutment blanks | |||||||||||
with a pre-machined implant connection | |||||||||||
where the upper portion may be custom- | |||||||||||
milled in accordance with a patient- | |||||||||||
specific design using CAD/CAM | |||||||||||
techniques; and 2) Titanium bases with a | |||||||||||
pre-machined implant connection upon | |||||||||||
which a CAD/CAM designed | |||||||||||
superstructure may be fitted to complete | |||||||||||
a two-piece dental abutment. The | |||||||||||
abutments include an abutment screw for | |||||||||||
fixation to the underlying implant. The | |||||||||||
abutments may be used for single-unit | |||||||||||
(single-tooth) or multiple-unit (bridges | |||||||||||
and bars) restorations and are compatible | |||||||||||
for use with BioHorizons Internal and | |||||||||||
Tapered Internal implant systems and | |||||||||||
Zimmer® Dental Screw-Vent® and | |||||||||||
Tapered Screw-Vent® implants with | |||||||||||
3.5mm, 4.5mm and 5.7mm internal hex- | |||||||||||
connection mating platform diameters. | |||||||||||
All digitally designed abutments and/or | |||||||||||
copings for use with BioHorizons | |||||||||||
CAD/CAM Abutments are intended to | |||||||||||
be sent to a BioHorizons-validated | |||||||||||
milling center for manufacture. | |||||||||||
BioHorizons abutments designed using | |||||||||||
CAD/CAM techniques must fulfill the | |||||||||||
BioHorizons allowable range of design | |||||||||||
parameters. | The CORE 3D abutment system for | ||||||||||
digital prosthetic solutions are dental | |||||||||||
abutments placed into a dental implant to | |||||||||||
provide support for dental prosthetic | |||||||||||
restorations. The abutments include: | |||||||||||
• Titanium Bases to be attached to the | |||||||||||
underlying implant and upon which a | |||||||||||
CAD/CAM designed superstructure | |||||||||||
may be fitted to complete a two- | |||||||||||
piece dental abutment; | |||||||||||
• Titanium Abutment Blanks with a | |||||||||||
pre-machined implant connection | |||||||||||
where the upper portion may be | |||||||||||
custom-milled in accordance with a | |||||||||||
patient-specific design using | |||||||||||
CAD/CAM techniques: | |||||||||||
• Abutment Screws to permanently fix | |||||||||||
the abutments to the underlying | |||||||||||
implant. | |||||||||||
Core 3D abutments are intended for use | |||||||||||
to support single-tooth (unit) and | |||||||||||
multiple-tooth (bridges and bars) | |||||||||||
prostheses, in the mandible or maxilla for | |||||||||||
functional and aesthetic restorations. | |||||||||||
Core 3D abutments designed using | |||||||||||
CAD/CAM techniques must fulfill the | |||||||||||
Core 3D allowable range of design | |||||||||||
specifications and be provided as straight | |||||||||||
abutments only. | |||||||||||
Core 3D abutments and are compatible | |||||||||||
for use with the following dental | |||||||||||
implants: | |||||||||||
• Nobel Biocare® Branemark | |||||||||||
System™ (K022562, K934825) | |||||||||||
• Zimmer® Tapered Screwvent® | |||||||||||
(K013227, K061410, K072589) | Ti-Base for individual Zirconium Abutments: The | ||||||||||
devices covered by this submission are abutments | |||||||||||
which are placed into a dental implant to provide | |||||||||||
support for a prosthetic restoration. | |||||||||||
The Ti-Base for individual Zirconium Abutments are | |||||||||||
intended for use to support a prosthetic device in a | |||||||||||
partially or completely edentulous patient. It is | |||||||||||
intended for use to support single and multiple tooth | |||||||||||
prosthesis, in the mandible or maxilla. The prosthesis | |||||||||||
can be cement retained to the abutment. The | |||||||||||
abutment screw is intended to secure the abutment to | |||||||||||
the endosseous implant. | |||||||||||
The Ti-Base abutments are indicated for use with the | |||||||||||
following implant systems: | |||||||||||
• Nobel Biocare® Replace Select® | |||||||||||
• Nobel Biocare No be !Active™ | |||||||||||
• Biomet 3i® Osseotite® | |||||||||||
• Biomet 3i® Osseotite® Certain® | |||||||||||
• Nobel Biocare Branemark® | |||||||||||
• Straumann® synOcta® | |||||||||||
• Straumann® Bone Level® | |||||||||||
• Zimmer® Tapered Screw-vent® | |||||||||||
• Astra Tech OsseoSpeed® | |||||||||||
• Dentsply-Friadent® Frialit® | |||||||||||
2-CONnect Abutment for Bridges and Bars: 2- | |||||||||||
CONnect Abutment for Bridges and Bars is indicated | |||||||||||
for use to provide support for prosthetic restorations | |||||||||||
such as bars and bridges. The 2-CONnect abutments | |||||||||||
can be used in multiple tooth restorations. The 2- | |||||||||||
CONnect abutment can be used together with | |||||||||||
cemented bridges and bar constructions for functional | |||||||||||
and aesthetical reconstruction. | |||||||||||
The 2-CONnect abutments are indicated for use with | |||||||||||
the following implant systems: | |||||||||||
• Nobel Biocare® Replace Select® | |||||||||||
• Straumann® synOcta® | BioHorizons Abutments for Zimmer are | ||||||||||
abutments that include healing abutments | |||||||||||
for contouring tissue and final restorative | |||||||||||
abutments to support a prosthesis. The | |||||||||||
abutments may be used for a single or | |||||||||||
multiple unit restoration and are | |||||||||||
compatible for use with BioHorizons | |||||||||||
Internal and Tapered Internal implant | |||||||||||
systems and Zimmer® Dental Screw- | |||||||||||
Vent® and Tapered Screw-Vent® | |||||||||||
implants with 3.5mm, 4.5mm and 5.7mm | |||||||||||
internal hex-connection mating platform | |||||||||||
diameters. | Implant Body | ||||||||||
Diameter | N/A | 3.8mm, 4.6mm, 5.8mm | 3.5mm, 4.0mm, 5.0mm, 6.0mm | 3.4mm, 3.8mm, 4.6mm, 5.8mm | 3.3mm, 3.7mm, 4.1mm, 4.7mm, | ||||||
6.0mm | |||||||||||
Subject Device | Primary Predicate Device | Reference Predicate Devices | Implant length | N/A | 7.5mm (except 3.8mm body), 9mm, | ||||||
10.5mm, 12mm, 15mm | 9mm, 10.5mm, 12mm, 15mm | 7.5mm (except 3.8mm body), 9mm, | |||||||||
10.5mm, 12mm, 15mm, 18mm | |||||||||||
(except 5.8mm body) | 8mm, 10mm, 11.5mm, 13mm, | ||||||||||
16mm | |||||||||||
BioHorizons Implant Systems, | |||||||||||
Inc. | |||||||||||
BioHorizons CAD/CAM | |||||||||||
Abutments | Core 3D Abutment System for | ||||||||||
Digital Prosthetic Solutions | |||||||||||
K122295 | NT-Trading Ti-Base Abutment, 2- | ||||||||||
CONnect Abutment | |||||||||||
K111935 | BioHorizons Implant Systems, | ||||||||||
Inc. | |||||||||||
BioHorizons Abutments for | |||||||||||
Zimmer K103691 | External | ||||||||||
thread | N/A | Buttress | Square | Buttress | V-shaped (Triple-Lead Thread) | ||||||
Design | Surface | All abutments (except 3.0mm | |||||||||
platform): Anodized on the hex | |||||||||||
connection | |||||||||||
Select abutments: TiN coated; Laser- | |||||||||||
Lok in specified zone between | |||||||||||
prosthetic margin and the implant- | |||||||||||
abutment junction (IAJ) | Implant - RBT | ||||||||||
Collar - Laser-Lok | Implant - RBT or HA | ||||||||||
Collar - Laser-Lok or RBT | Implant - RBT or HA | ||||||||||
Collar - Laser-Lok or RBT | Implant - MTX Microtexture or | ||||||||||
HA | |||||||||||
Collar - Machined | |||||||||||
Surface | All abutments (except 3.0mm | ||||||||||
platform): Anodized on the hex | |||||||||||
connection | |||||||||||
Select abutments: TiN coated; | |||||||||||
Laser-Lok in specified zone | |||||||||||
between prosthetic margin and | |||||||||||
the implant-abutment junction | |||||||||||
(IAJ) | Not known | Not known | All abutments: Anodized on the | ||||||||
hex connection | |||||||||||
Select abutments: TiN coated; | |||||||||||
Laser-Lok in specified zone | |||||||||||
between prosthetic margin and the | |||||||||||
implant-abutment junction (IAJ) | Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Internal Hex | |||||
Laser-Lok | |||||||||||
Zone | Groove size: 8µm width and | ||||||||||
depth | |||||||||||
Min. height (vertical dimension): | |||||||||||
0.5mm | N/A | N/A | Groove size: 8µm width and depth | ||||||||
Min. height (vertical dimension): | |||||||||||
0.5mm | Internal | ||||||||||
thread | N/A | Spiralock UNF 1-72 | Spiralock UNF 1-72 | Spiralock UNF 1-72 | UNF 1-72 | ||||||
Connection | Internal Hex | Varies, External and Internal | |||||||||
dependent on implant system | |||||||||||
compatibility | Varies, dependent on implant system | ||||||||||
compatibility | Internal Hex | Prosthetic | |||||||||
platform | 3.0mm, 3.5mm, 4.5mm, 5.7mm | 3.0mm, 3.5mm, 4.5mm | 3.5mm, 4.5mm, 5.7mm | 3.0mm, 3.5mm, 4.5mm, 5.7mm | 3.5mm, 4.5mm, 5.7mm | ||||||
Prosthetic | |||||||||||
platform | 3.0mm, 3.5mm, 4.5mm, 5.7mm | 3.5mm, 4.1mm, 4.5mm, 5.1mm, | |||||||||
5.7mm | 3.5mm (minimum), 6.5mm (maximum) | 3.5mm, 4.5mm, 5.7mm | Material and Manufacturing | ||||||||
Angulation | Custom Ti (blanks): 0°-30° | ||||||||||
Ti Base (ceramic): 0°-20° | Not known | Not known | 0°-20° | Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Titanium (commercially pure) | ||
Abutment | |||||||||||
Screw Included | Yes | Yes | Yes | Yes | Manufacturing | ||||||
process | Machined by BioHorizons or A-level | ||||||||||
supplier, select models are surface | |||||||||||
treated with micro-machined grooves | |||||||||||
(Laser-Lok), TiN coating and | |||||||||||
anodized on the hex connection | |||||||||||
(except 3.0mm hex) | Machined by BioHorizons or A-level | ||||||||||
supplier, anodized for color, collar | |||||||||||
micro-machined with grooves, | |||||||||||
threaded surface treated with RBT, | |||||||||||
passivated per ASTM F86 | Machined by BioHorizons or A-level | ||||||||||
supplier, anodized for color, collar | |||||||||||
micro-machined with grooves, | |||||||||||
threaded surface treated with RBT or | |||||||||||
HA, passivated per ASTM F86 | Machined by BioHorizons or A-level | ||||||||||
supplier, anodized for color, collar | |||||||||||
micro-machined with grooves, | |||||||||||
threaded surface treated with RBT or | |||||||||||
HA, passivated per ASTM F86 | Not known | ||||||||||
Mode of | |||||||||||
retention | Screw-retained to the implant; | ||||||||||
the prosthesis can be cement | |||||||||||
retained to the abutment | Screw-retained to the implant; the | ||||||||||
prosthesis can be cement retained | |||||||||||
to the abutment | Screw-retained or cement retained | Screw-retained to the implant; the | |||||||||
prosthesis can be cement retained | |||||||||||
to the abutment | Packaging | Poly/Tyvek pouch | Tyvek-lidded blister tray | Tyvek-lidded blister tray | Tyvek-lidded blister tray | Plastic vial with tamper-evident | |||||
cap | |||||||||||
Material and Packaging | Sterilization | N/A; provided non-sterile, steam | |||||||||
sterilization in accordance with | |||||||||||
qualified cycles as specified in the | |||||||||||
Instructions for Use | 25-40 kGy gamma irradiation dose | ||||||||||
range | 25-40 kGy gamma irradiation dose | ||||||||||
range | 25-40 kGy gamma irradiation dose | ||||||||||
range | Gamma irradiation; dose range not | ||||||||||
known | |||||||||||
Abutment | |||||||||||
Material | Ti-6Al-4V (ASTM F136); | ||||||||||
additionally, Y-TZP Ceramic for | |||||||||||
Titanium Base Abutment | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V (ASTM F136), Gold | ||||||||
Alloy 6019, Y-TZP Ceramic, | |||||||||||
PEEK | |||||||||||
Packaging | Poly/Tyvek pouch | Not known | Not known | Sterile Abutments: Poly/Tyvek | |||||||
pouch inside plastic support tub | |||||||||||
Non-sterile Abutments: Poly/Tyvek | |||||||||||
pouch |
7
Table 1. Summary Table of Substantial Equivalence (cont.)
8