K Number
K151621
Device Name
BioHorizons CAD/CAM Abutments
Date Cleared
2016-01-13

(211 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
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.
More Information

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.

K122295

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:

    1. K122295, Core 3D Abutment System for Digital Prosthetic Solutions, October 24, 2013.
      Reference Predicate Devices:
    1. K111935, NT-Trading Ti-Base Abutment, 2-CONnect Abutment, February 17, 2012.
    1. K103691, BioHorizons Abutments for Zimmer, November 3, 2011.
    1. K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012.
    1. K073268, BioHorizons Internal Implant System, February 8, 2008.
    1. K071638, BioHorizons Tapered Internal Implant System, October 10, 2007.
    1. K143022, BioHorizons Tapered Internal Implant System, January 8, 2015.
    1. 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.

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Table 1. Summary Table of Substantial Equivalence

Subject DevicePrimary Predicate DeviceReference Predicate DevicesCompatible Implant Devices
BioHorizons Implant Systems,
Inc.
BioHorizons CAD/CAM
AbutmentsCore 3D Abutment System for
Digital Prosthetic Solutions
K122295NT-Trading Ti-Base Abutment, 2-
CONnect Abutment
K111935BioHorizons Implant Systems,
Inc.
BioHorizons Abutments for
Zimmer K103691Subject DeviceBioHorizons Implant Systems, Inc.
BioHorizons CAD/CAM
AbutmentsBioHorizons Implant Systems, Inc.
Tapered Internal Plus Implants
K121787BioHorizons Implant Systems, Inc.
Internal Implant System
K073268BioHorizons Implant Systems, Inc.
Tapered Internal Implant System
K071638 & K143022Zimmer® Dental (formerly
Sulzer Dental) Screw-Vent® and
Tapered Screw-Vent® Systems
K013227
Classification/
Product Code872.3630/NHA872.3630/NHA872.3630/NHA872.3630/NHADesign
Intended UseBioHorizons 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
DiameterN/A3.8mm, 4.6mm, 5.8mm3.5mm, 4.0mm, 5.0mm, 6.0mm3.4mm, 3.8mm, 4.6mm, 5.8mm3.3mm, 3.7mm, 4.1mm, 4.7mm,
6.0mm
Subject DevicePrimary Predicate DeviceReference Predicate DevicesImplant lengthN/A7.5mm (except 3.8mm body), 9mm,
10.5mm, 12mm, 15mm9mm, 10.5mm, 12mm, 15mm7.5mm (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
AbutmentsCore 3D Abutment System for
Digital Prosthetic Solutions
K122295NT-Trading Ti-Base Abutment, 2-
CONnect Abutment
K111935BioHorizons Implant Systems,
Inc.
BioHorizons Abutments for
Zimmer K103691External
threadN/AButtressSquareButtressV-shaped (Triple-Lead Thread)
DesignSurfaceAll 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-LokImplant - RBT or HA
Collar - Laser-Lok or RBTImplant - RBT or HA
Collar - Laser-Lok or RBTImplant - MTX Microtexture or
HA
Collar - Machined
SurfaceAll 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 knownNot knownAll abutments: Anodized on the
hex connection
Select abutments: TiN coated;
Laser-Lok in specified zone
between prosthetic margin and the
implant-abutment junction (IAJ)ConnectionInternal HexInternal HexInternal HexInternal HexInternal Hex
Laser-Lok
ZoneGroove size: 8µm width and
depth
Min. height (vertical dimension):
0.5mmN/AN/AGroove size: 8µm width and depth
Min. height (vertical dimension):
0.5mmInternal
threadN/ASpiralock UNF 1-72Spiralock UNF 1-72Spiralock UNF 1-72UNF 1-72
ConnectionInternal HexVaries, External and Internal
dependent on implant system
compatibilityVaries, dependent on implant system
compatibilityInternal HexProsthetic
platform3.0mm, 3.5mm, 4.5mm, 5.7mm3.0mm, 3.5mm, 4.5mm3.5mm, 4.5mm, 5.7mm3.0mm, 3.5mm, 4.5mm, 5.7mm3.5mm, 4.5mm, 5.7mm
Prosthetic
platform3.0mm, 3.5mm, 4.5mm, 5.7mm3.5mm, 4.1mm, 4.5mm, 5.1mm,
5.7mm3.5mm (minimum), 6.5mm (maximum)3.5mm, 4.5mm, 5.7mmMaterial and Manufacturing
AngulationCustom Ti (blanks): 0°-30°
Ti Base (ceramic): 0°-20°Not knownNot known0°-20°MaterialTi-6Al-4V (ASTM F136)Ti-6Al-4V (ASTM F136)Ti-6Al-4V (ASTM F136)Ti-6Al-4V (ASTM F136)Titanium (commercially pure)
Abutment
Screw IncludedYesYesYesYesManufacturing
processMachined 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 F86Machined by BioHorizons or A-level
supplier, anodized for color, collar
micro-machined with grooves,
threaded surface treated with RBT or
HA, passivated per ASTM F86Machined by BioHorizons or A-level
supplier, anodized for color, collar
micro-machined with grooves,
threaded surface treated with RBT or
HA, passivated per ASTM F86Not known
Mode of
retentionScrew-retained to the implant;
the prosthesis can be cement
retained to the abutmentScrew-retained to the implant; the
prosthesis can be cement retained
to the abutmentScrew-retained or cement retainedScrew-retained to the implant; the
prosthesis can be cement retained
to the abutmentPackagingPoly/Tyvek pouchTyvek-lidded blister trayTyvek-lidded blister trayTyvek-lidded blister trayPlastic vial with tamper-evident
cap
Material and PackagingSterilizationN/A; provided non-sterile, steam
sterilization in accordance with
qualified cycles as specified in the
Instructions for Use25-40 kGy gamma irradiation dose
range25-40 kGy gamma irradiation dose
range25-40 kGy gamma irradiation dose
rangeGamma irradiation; dose range not
known
Abutment
MaterialTi-6Al-4V (ASTM F136);
additionally, Y-TZP Ceramic for
Titanium Base AbutmentTi-6Al-4VTi-6Al-4VTi-6Al-4V (ASTM F136), Gold
Alloy 6019, Y-TZP Ceramic,
PEEK
PackagingPoly/Tyvek pouchNot knownNot knownSterile Abutments: Poly/Tyvek
pouch inside plastic support tub
Non-sterile Abutments: Poly/Tyvek
pouch

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Table 1. Summary Table of Substantial Equivalence (cont.)

8