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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BioHorizons CAD/CAM Abutments:

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k)). This means the "acceptance criteria" are largely based on showing the device performs comparably to existing, legally marketed devices, rather than establishing de novo performance targets. The "studies" are tests conducted to support this claim of equivalence.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria in a typical pass/fail format with specific thresholds. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant industry standards. The reported device performance is demonstrated through various tests designed to show that the BioHorizons CAD/CAM Abutments perform in accordance with their intended use and are substantially equivalent to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Fatigue Strength (per ISO 14801 & FDA Guidance)	"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." (Implies meeting or exceeding the performance established by the standard and predicate devices for similar angled abutments).
Implant Compatibility	"Compatibility testing was performed on a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants... 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." (Implies successful and reliable fit/function with listed implant systems).
Sterilization Efficacy (for non-sterile devices requiring sterilization by user)	"Steam sterilization validation testing was performed new in accordance with AAMI/ANSVISO 17665-1:2006... Test results demonstrate a sterility assurance level (SAL) of 10⁻⁶." (Implies achievement of the industry-standard sterility level after a validated sterilization process).
Software Validation (for CAD/CAM design parameters)	"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." (Implies the software correctly enforces design constraints to ensure proper abutment manufacturing).
Substantial Equivalence (Overall Safety & Effectiveness)	"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." (This is the overarching conclusion of the submission, supported by all the aforementioned tests and comparisons).

Further Details on the Study:

Given the nature of this 510(k) submission for a dental abutment, it's highly unlikely that components like "test sets," "ground truth experts," "adjudication methods," or "MRMC comparative effectiveness studies" were part of the presented data. These concepts are more typically associated with diagnostic imaging AI/ML devices or clinical trials involving complex human interpretation.

Therefore, many of the requested items below will be marked as "Not Applicable" or "Not Provided" based on the document's content and the typical scope of device approval for implant components.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for compliance with the respective standards (e.g., ISO 14801 typically requires 12 samples per group for fatigue testing). The document mentions "worst-case 30° angled configurations" and "representative subset" for compatibility testing.
- Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The document does not indicate data from human subjects or clinical sites.
- Retrospective or Prospective: Not applicable as these are laboratory and validation tests, not clinical studies involving patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The "ground truth" for mechanical and sterilization testing is defined by the physical properties measured against engineering standards (e.g., fracture strength, SAL level). For software validation, it's the correct implementation of defined design parameters. No human expert "ground truthing" in the sense of clinical interpretation is relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Adjudication methods are relevant for ambiguous human interpretations, which is not the case for material property or mechanical performance testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not a diagnostic device involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Directly Applicable. While software validation for the CAD/CAM milling process was performed (an "algorithm only" component), this isn't a standalone diagnostic AI. Its "performance" is about correctly enforcing design parameters, not making a diagnosis or prediction. The core device is a physical product, not a software algorithm presented for standalone performance evaluation in a clinical context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards / Defined Specifications:
  - For Dynamic Mechanical Fatigue: ISO 14801 standards and BioHorizons' internal performance specifications for expected strength and durability.
  - For Compatibility: Physical fit and function with the specified implant systems.
  - For Sterilization: AAMI/ANSVISO 17665-1:2006, specifically achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
  - For Software: BioHorizons' allowable range of design parameters and criteria.
The sample size for the training set
- Not Applicable. As a physical medical device submission, there is no "training set" in the context of machine learning algorithms. The design process for the abutments is based on engineering principles and existing product lines, not data training.
How the ground truth for the training set was established
- Not Applicable. (See above, no training set for this type of device submission).

Summary

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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.

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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

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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.

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)

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510(k) Summary 21 CFR 807.92

Submitter's Name & Address

Manufacturer:	BioHorizons Implant Systems, Inc.2300 Riverchase CenterBirmingham, AL 35244Phone (205) 967-7880Fax (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

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

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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.

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.

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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 Device	Primary Predicate Device	Reference Predicate Devices				Compatible Implant Devices
	BioHorizons Implant Systems,Inc.BioHorizons CAD/CAMAbutments	Core 3D Abutment System forDigital Prosthetic SolutionsK122295	NT-Trading Ti-Base Abutment, 2-CONnect AbutmentK111935	BioHorizons Implant Systems,Inc.BioHorizons Abutments forZimmer K103691		Subject Device	BioHorizons Implant Systems, Inc.BioHorizons CAD/CAMAbutments	BioHorizons Implant Systems, Inc.Tapered Internal Plus ImplantsK121787	BioHorizons Implant Systems, Inc.Internal Implant SystemK073268	BioHorizons Implant Systems, Inc.Tapered Internal Implant SystemK071638 & K143022	Zimmer® Dental (formerlySulzer Dental) Screw-Vent® andTapered Screw-Vent® SystemsK013227
Classification/Product Code	872.3630/NHA	872.3630/NHA	872.3630/NHA	872.3630/NHA	Design
Intended Use	BioHorizons CAD/CAM Abutments aredental abutments placed onto a dentalimplant to provide support for dentalprosthetic restorations. The abutmentsinclude: 1) Titanium abutment blankswith a pre-machined implant connectionwhere the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAMtechniques; and 2) Titanium bases with apre-machined implant connection uponwhich a CAD/CAM designedsuperstructure may be fitted to completea two-piece dental abutment. Theabutments include an abutment screw forfixation to the underlying implant. Theabutments may be used for single-unit(single-tooth) or multiple-unit (bridgesand bars) restorations and are compatiblefor use with BioHorizons Internal andTapered Internal implant systems andZimmer® Dental Screw-Vent® andTapered Screw-Vent® implants with3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.All digitally designed abutments and/orcopings for use with BioHorizonsCAD/CAM Abutments are intended tobe sent to a BioHorizons-validatedmilling center for manufacture.BioHorizons abutments designed usingCAD/CAM techniques must fulfill theBioHorizons allowable range of designparameters.	The CORE 3D abutment system fordigital prosthetic solutions are dentalabutments placed into a dental implant toprovide support for dental prostheticrestorations. The abutments include:• Titanium Bases to be attached to theunderlying implant and upon which aCAD/CAM designed superstructuremay be fitted to complete a two-piece dental abutment;• Titanium Abutment Blanks with apre-machined implant connectionwhere the upper portion may becustom-milled in accordance with apatient-specific design usingCAD/CAM techniques:• Abutment Screws to permanently fixthe abutments to the underlyingimplant.Core 3D abutments are intended for useto support single-tooth (unit) andmultiple-tooth (bridges and bars)prostheses, in the mandible or maxilla forfunctional and aesthetic restorations.Core 3D abutments designed usingCAD/CAM techniques must fulfill theCore 3D allowable range of designspecifications and be provided as straightabutments only.Core 3D abutments and are compatiblefor use with the following dentalimplants:• Nobel Biocare® BranemarkSystem™ (K022562, K934825)• Zimmer® Tapered Screwvent®(K013227, K061410, K072589)	Ti-Base for individual Zirconium Abutments: Thedevices covered by this submission are abutmentswhich are placed into a dental implant to providesupport for a prosthetic restoration.The Ti-Base for individual Zirconium Abutments areintended for use to support a prosthetic device in apartially or completely edentulous patient. It isintended for use to support single and multiple toothprosthesis, in the mandible or maxilla. The prosthesiscan be cement retained to the abutment. Theabutment screw is intended to secure the abutment tothe endosseous implant.The Ti-Base abutments are indicated for use with thefollowing 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 indicatedfor use to provide support for prosthetic restorationssuch as bars and bridges. The 2-CONnect abutmentscan be used in multiple tooth restorations. The 2-CONnect abutment can be used together withcemented bridges and bar constructions for functionaland aesthetical reconstruction.The 2-CONnect abutments are indicated for use withthe following implant systems:• Nobel Biocare® Replace Select®• Straumann® synOcta®	BioHorizons Abutments for Zimmer areabutments that include healing abutmentsfor contouring tissue and final restorativeabutments to support a prosthesis. Theabutments may be used for a single ormultiple unit restoration and arecompatible for use with BioHorizonsInternal and Tapered Internal implantsystems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent®implants with 3.5mm, 4.5mm and 5.7mminternal hex-connection mating platformdiameters.	Implant BodyDiameter		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/CAMAbutments	Core 3D Abutment System forDigital Prosthetic SolutionsK122295	NT-Trading Ti-Base Abutment, 2-CONnect AbutmentK111935	BioHorizons Implant Systems,Inc.BioHorizons Abutments forZimmer K103691	Externalthread		N/A	Buttress	Square	Buttress	V-shaped (Triple-Lead Thread)
Design					Surface		All abutments (except 3.0mmplatform): Anodized on the hexconnectionSelect abutments: TiN coated; Laser-Lok in specified zone betweenprosthetic margin and the implant-abutment junction (IAJ)	Implant - RBTCollar - Laser-Lok	Implant - RBT or HACollar - Laser-Lok or RBT	Implant - RBT or HACollar - Laser-Lok or RBT	Implant - MTX Microtexture orHACollar - Machined
Surface	All abutments (except 3.0mmplatform): Anodized on the hexconnectionSelect abutments: TiN coated;Laser-Lok in specified zonebetween prosthetic margin andthe implant-abutment junction(IAJ)	Not known	Not known	All abutments: Anodized on thehex connectionSelect abutments: TiN coated;Laser-Lok in specified zonebetween prosthetic margin and theimplant-abutment junction (IAJ)	Connection		Internal Hex	Internal Hex	Internal Hex	Internal Hex	Internal Hex
Laser-LokZone	Groove size: 8µm width anddepthMin. height (vertical dimension):0.5mm	N/A	N/A	Groove size: 8µm width and depthMin. height (vertical dimension):0.5mm	Internalthread		N/A	Spiralock UNF 1-72	Spiralock UNF 1-72	Spiralock UNF 1-72	UNF 1-72
Connection	Internal Hex	Varies, External and Internaldependent on implant systemcompatibility	Varies, dependent on implant systemcompatibility	Internal Hex	Prostheticplatform		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
Prostheticplatform	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)
AbutmentScrew Included	Yes	Yes	Yes	Yes	Manufacturingprocess		Machined by BioHorizons or A-levelsupplier, select models are surfacetreated with micro-machined grooves(Laser-Lok), TiN coating andanodized on the hex connection(except 3.0mm hex)	Machined by BioHorizons or A-levelsupplier, anodized for color, collarmicro-machined with grooves,threaded surface treated with RBT,passivated per ASTM F86	Machined by BioHorizons or A-levelsupplier, anodized for color, collarmicro-machined with grooves,threaded surface treated with RBT orHA, passivated per ASTM F86	Machined by BioHorizons or A-levelsupplier, anodized for color, collarmicro-machined with grooves,threaded surface treated with RBT orHA, passivated per ASTM F86	Not known
Mode ofretention	Screw-retained to the implant;the prosthesis can be cementretained to the abutment	Screw-retained to the implant; theprosthesis can be cement retainedto the abutment	Screw-retained or cement retained	Screw-retained to the implant; theprosthesis can be cement retainedto the abutment	Packaging		Poly/Tyvek pouch	Tyvek-lidded blister tray	Tyvek-lidded blister tray	Tyvek-lidded blister tray	Plastic vial with tamper-evidentcap
Material and Packaging					Sterilization		N/A; provided non-sterile, steamsterilization in accordance withqualified cycles as specified in theInstructions for Use	25-40 kGy gamma irradiation doserange	25-40 kGy gamma irradiation doserange	25-40 kGy gamma irradiation doserange	Gamma irradiation; dose range notknown
AbutmentMaterial	Ti-6Al-4V (ASTM F136);additionally, Y-TZP Ceramic forTitanium Base Abutment	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V (ASTM F136), GoldAlloy 6019, Y-TZP Ceramic,PEEK
Packaging	Poly/Tyvek pouch	Not known	Not known	Sterile Abutments: Poly/Tyvekpouch inside plastic support tubNon-sterile Abutments: Poly/Tyvekpouch

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

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Regulation Number and Section

§ 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.)