BioHorizons Tapered IM Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Device Description

The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic platform. The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surqical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a dental implant device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a human-in-the-loop or standalone AI/software study.

Therefore, many of the requested points regarding acceptance criteria and performance study details (like sample size, number of experts, adjudication, MRMC, standalone performance, training data, etc.) are not applicable to this type of submission. This document describes a medical device (a dental implant), not a diagnostic AI or imaging device that would typically involve such performance metrics and studies.

However, I can extract the relevant information pertaining to the "acceptance criteria" and "study" as presented in the context of this 510(k) submission, which are focused on physical and mechanical properties of the implant and demonstrating its safety and effectiveness through substantial equivalence.

Here's a breakdown based on the provided document:

Relevance of the Document to the Request:

This document is a 510(k) Premarket Notification for a dental implant (a physical medical device). The primary objective of a 510(k) submission is to demonstrate that the new device is substantially equivalent (SE) to a legally marketed predicate device, meaning it is as safe and effective as the predicate. This is different from a clinical trial or performance study typically conducted for AI/software-as-a-medical-device (SaMD) where metrics like sensitivity, specificity, or reader accuracy are paramount.

Therefore, many of the questions asked in the prompt, which are highly relevant to SaMD performance studies, are not directly addressed or applicable in this document about a physical dental implant.

Acceptance Criteria and Study for BioHorizons Tapered IM Implants (based on provided text):

The "acceptance criteria" and "study" in this context refer to the engineering and quality control measures to demonstrate the new implant's mechanical integrity, material compatibility, and manufacturing consistency, primarily by comparing it to already cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (as stated or inferred)	Reported Device Performance (Compliance)
Mechanical Strength (Design)	Tapered IM implant connection geometry, in relation to the implant external profile, shall have equal or greater (≥) wall thickness compared to the Tapered Internal Plus implant and the Tapered Internal implant (worst-case predicate devices).	Met: A comparative dimensional assessment was performed, and the Tapered IM implant design was found to be comparable or superior in wall thickness to the worst-case predicate devices.
Mechanical Strength (Fatigue)	Dynamic mechanical fatigue testing (ISO 14801) for worst-case predicate devices: implant-abutment assemblies survived three consecutive fatigue runouts for 5 million cycles. (This is a historical acceptance for the predicate, implicitly indicating the subject device must also be sufficiently robust due to comparable design).	Met (by reference to predicate): A retrospective review of mechanical testing for the predicate Tapered Internal Plus implant and Tapered Internal Implant showed successful fatigue testing (survived 3 consecutive fatigue runouts for 5 million cycles). The document states, "The aforementioned comparative dimensional assessment combined with the successful fatigue testing of the worst-case predicate device qualify the Tapered Internal IM implants for their intended use."
Sterilization Assurance Level	Minimum sterility assurance level of 10⁻⁶, validated in compliance with ANSI/AAMI/ISO 11137-1.	Met: "Sterilization validation was evaluated in accordance with ANSI/AAMI/ISO 11137-1. Validation parameters were established for this device and are substantially equivalent to those used in the primary predicate device cleared under K121787." (Implies compliance with 10⁻⁶ SAL).
Endotoxin Levels	Endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP <161>.	Met: "Testing consistently demonstrates that endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP <161>."
Material Composition	Meet chemical requirements of ASTM F136 (Ti-6Al-4V ELI).	Met: "BioHorizons Tapered IM Implants meet the chemical requirements of ASTM F136."
Surface Treatment	Consistency and substantial equivalence of RBT (Resorbable Blast Texture) and Laser-Lok microchannels to existing cleared devices.	Met: "The surface and processing used in this device are substantially equivalent to those used in the reference predicate device cleared under K071638." and "The Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Plus Implants."
Biocompatibility	Material (Ti-6Al-4V) commonly used in surgical implant applications, ensuring no special biocompatibility testing is required beyond what is established for this class of material.	Met (by reference to established material): "This grade of Titanium is commonly used in surgical implant applications thus no special biocompatibility testing was conducted for the proposed devices." The material is substantially equivalent to that used in K071638.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (for dimensional assessment): Not explicitly stated as a numerical sample size. It refers to "the worst-case subject Tapered IM implant device (smallest implant body diameter combined with the shortest implant length)." This implies a single representative sample was chosen for a comparative dimensional analysis, demonstrating a specific design characteristic rather than a statistical test on a batch.
Test Set (for mechanical fatigue): Not explicitly stated for the subject device. For the predicate devices, which were used to establish equivalence, the test involved the "worst-case 3.8mm x 15mm Tapered Internal Plus implant assembled with a 3.0mm Angled Esthetic Abutment" and "the worst-case 3.8mm x 15mm Tapered Internal implant assembled with a 3.5mm Angled Custom Abutment." The phrase "three consecutive fatigue runouts" suggests at least three samples of the predicate devices were tested to 5 million cycles.
Data Provenance: The data are from BioHorizons Implant Systems, Inc., a U.S.-based company. The studies referenced (dimensional assessment, retrospective mechanical testing, sterilization validation, endotoxin testing, material conformity) are internal or industry-standard tests; the document implies typical
- Retrospective for the mechanical testing of the predicate devices (data was already available from previous 510(k)s).
- Prospective/Current Quality Control for endotoxin testing, sterilization validation, and the dimensional assessment of the subject device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not Applicable. This document pertains to the physical and mechanical properties of a dental implant, not a diagnostic task requiring expert human interpretation of data/images to establish ground truth for a test set. Ground truth for these tests is based on engineering measurements, physical endurance testing, chemical analysis, and microbiological validation, conforming to industry standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

Not Applicable. As above, no human "adjudication" in the sense of reconciling clinical interpretations is required for physical and mechanical testing of a device. The results are from quantifiable measurements and standard methods.

5. 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:

Not Applicable. This is a 510(k) for a physical dental implant, not an AI/software device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This is not an algorithm or software device. The "standalone performance" here refers to the device's physical performance (e.g., strength, material properties) as demonstrated through engineering tests.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established through:
- Engineering Specifications and Measurements: For dimensional assessment (wall thickness).
- Mechanical Testing Standards: For fatigue testing (meeting ISO 14801 standards and surviving specified cycles).
- Material Standards and Chemical Analysis: For material composition (ASTM F136).
- Sterilization Standards and Validation: For sterility (ANSI/AAMI/ISO 11137-1).
- Microbiological Standards: For endotoxin levels (USP <161>).
- Established Predicate Device Performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices, which the new device is demonstrated to be similar to in design, materials, and function, with comparable or superior performance in key engineering metrics.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. (See #8)

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 10, 2018

BioHorizons Implant Systems, Inc. Michael Davis Director, Regulatory Affairs 2300 Riverchase Center Birmingham, Alabama 35244

Re: K182070

Trade/Device Name: BioHorizons Tapered IM Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 7, 2018 Received: September 11, 2018

Dear Michael 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting 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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510(k) Summarv 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 Affairs
Date prepared:	October 10, 2018

Name of the Device

Trade Name:	BioHorizons Tapered IM Implants
Common or Usual Name:	Screw-type dental implant
Classification Name:	Endosseous dental implant
Classification Number:	Class II (21 CFR 872.3640)

Predicate Devices

Primary Predicate Device:

1. K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012.

Reference Predicate Devices:

1. K103691, BioHorizons Abutments for Zimmer, November 3, 2011.
1. K151621, BioHorizons CAD/CAM Abutments, January 13, 2016.
1. K071638. BioHorizons Tapered Internal Implant System, October 10, 2017.
1. K071161, Endosseous Dental Implant System, November 16, 2007.

Device Description

The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

Indications for Use

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Technological Characteristics

The fundamental scientific technology of the BioHorizons Tapered IM endosseous dental implant devices subject to this 510(k) is substantially equivalent to the primary predicate device. The threaded portion of the implants is RBT-blasted, and Laser-Lok microchannels are applied to the implant collar.

Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the collar of a dental implant, providing a roughened surface to establish a physical, connective tissue attachment. This tissue connection:

1. is functionally oriented,
1. inhibits epithelial cell downgrowth, and
1. enables crestal bone adjacent to the implant to attach and be retained

The preceding claims are supported in the published literature by Nevins et al. Human Histologic Evidence of a Connective Tissue Attachment to a Dental Implant, International Journal of Periodontics & Restorative Dentistry 2008; 28:111-121 and Ricci et al. Bone Response to Laser Microtextured Surfaces, Bone Engineering 2000:382-392.

All materials, suppliers, processing, packaging and sterilization methods remain the same as for the primary predicate device, BioHorizons Tapered Internal Plus Implants (K121787). The Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Plus Implants. The BioHorizons Tapered IM Implants are substantially equivalent to the features of the predicate implant devices because of the similarities in design, materials and intended use. Refer to Table 1, Summary Table of Substantial Equivalence, immediately following.

Summary of Testing

A comparative dimensional assessment was performed comparing the worst-case subject Tapered IM implant device (smallest implant body diameter combined with the shortest implant length) to the worst-case predicate Tapered Internal Plus implant device and Tapered Internal implant device (smallest prosthetic platform/smallest implant body diameter combined with the shortest implant length). The intent of the assessment was to develop objective evidence that the Tapered IM implant is substantially equivalent to the Tapered Internal Plus implant and the Tapered Internal implant as it relates to design and mechanical strength. Acceptance criteria dictated that the Tapered IM implant connection geometry, in relation to the implant external profile, shall have equal or greater (≥) wall thickness compared to the Tapered Internal Plus implant and the Tapered Internal implant. In addition to the dimensional assessment, a retrospective review of mechanical testing for the predicate Tapered Internal Plus implant and Tapered Internal Implant was also performed. Dynamic mechanical fatigue testing was performed in accordance with ISO 14801, Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants for the worst-case 3.8mm x 15mm Tapered Internal Plus implant assembled with a 3.0mm Angled Esthetic Abutment and the worst-case 3.8mm x 15mm Tapered Internal implant assembled with a 3.5mm Angled Custom Abutment. The implant-abutment assemblies survived three consecutive fatigue runouts for 5 million cycles. The predicate device fatigue testing was included in the applicable 510(k). The aforementioned comparative dimensional assessment combined with the successful fatigue testing of the worst-case predicate device qualify the Tapered Internal IM implants for their intended use.

Sterilization validation was evaluated in accordance with ANSI/AAMI/ISO 11137-1. Validation parameters were established for this device and are substantially equivalent to those used in the primary predicate device cleared under K121787.

Endotoxin testing is routinely performed in accordance with ANSI/AAMI ST72. Testing consistently demonstrates that endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP <161>.

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Additional data relied on from BioHorizons previous dental implant device submissions to demonstrate substantial equivalence to the predicate devices includes evaluation of the RBT surface treatment process as is applied to all BioHorizons dental implant devices. The surface and processing used in this device are substantially equivalent to those used in the reference predicate device cleared under K071638.

Finally, BioHorizons Tapered IM Implants meet the chemical requirements of ASTM F136. This grade of Titanium is commonly used in surgical implant applications thus no special biocompatibility testing was conducted for the proposed devices. The material and processing used in this device are substantially equivalent to those used in the reference predicate device cleared under K071638.

Conclusion

The data presented in this submission demonstrates that the proposed device is substantially equivalent to the primary predicate devices with respect to performance and intended use. Any risks associated with differences noted in the Indications for Use of the proposed device and predicate devices have been mitigated by additional information included in the Warnings and Precautions section of the Instructions for Use. The additional information includes limiting use of the proposed device to the molar region, providing placement recommendations, and adding clinician considerations for use of these devices.

The proposed device performs as well as the legally marketed predicate devices. Furthermore. the proposed device does 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
	BioHorizons ImplantSystems, Inc.Tapered IM Implants	BioHorizons ImplantSystems, Inc.Tapered Internal PlusImplants	BioHorizons Implant Systems,Inc. Abutments for ZimmerK103691	BioHorizons Implant Systems,Inc.CAD/CAM AbutmentsK151621	BioHorizons Implant Systems,Inc.Tapered Internal ImplantSystemsK071638	Southern Implant -Endosseous DentalImplant SystemK071161
Intended Use	BioHorizons Tapered IMImplants are intended for use inthe mandible or maxilla for useas an artificial root structure forsingle tooth replacement or forfixed bridgework and dentalretention.BioHorizons Tapered IMImplants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion, or2) when splinted together formultiple tooth replacement,or when stabilized with anoverdenture supported bymultiple implants.	BioHorizons Tapered InternalPlus Implants are intended foruse in the mandible or maxillafor use as an artificial rootstructure for single toothreplacement or for fixedbridgework and dentalretention.BioHorizons Tapered InternalPlus Implants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion, or2) when splinted together formultiple tooth replacement,or when stabilized with anoverdenture supported bymultiple implants.	BioHorizons Abutments forZimmer® are abutments thatinclude healing abutments forcontouring tissue and finalrestorative abutments to supporta prosthesis. The abutmentsmay be used for a single ormultiple unit restoration and arecompatible for use withBioHorizons Internal and TaperedInternal implant systems andZimmer® Dental Screw-Vent® andTapered Screw-Vent® implantswith 3.5mm, 4.5mm and 5.7mminternal hex-connection matingplatform diameters.BioHorizons Titanium BaseAbutments and Laser-LokTitanium Base Abutments areintended to be used to be usedas straight abutments.	CAD/CAMAbutments are dental abutmentsplaced onto a dental implant toprovide support for dentalprosthetic restorations. Theabutments include: 1) Titaniumabutment blanks with a pre-machined implant connectionwhere the upper portion may becustom-milled in accordance witha patient-specific design usingCAD/CAM techniques; and 2)Titanium bases with a pre-machined implant connectionupon which a CAD/CAM designedsuperstructure may be fitted tocomplete a two-piece dentalabutment. The abutments includean abutment screw for fixation tothe underlying implant. Theabutments may be used forsingle-unit (single-tooth) ormultiple-unit (bridges and bars)restorations and are compatiblefor use with BioHorizons Internaland Tapered Internal implantsystems and Zimmer® DentalScrew-Vent® and TaperedScrew-Vent® implants with3.5mm, 4.5mm and 5.7mminternal hex-connection matingplatform diameters.All digitally designed abutmentsand/or copings for use withBioHorizons CAD/CAMAbutments are intended to besent to a BioHorizons-validatedmilling center for manufacture.BioHorizons abutments designedusing CAD/CAM techniques mustfulfill the BioHorizons allowablerange of design parameters.	BioHorizons Tapered InternalImplant Systems is intended foruse in the mandible or maxilla foruse as an artificial root structurefor single tooth replacement or forfixed bridgework and dentalretention.BioHorizons Tapered InternalImplants may be restoredimmediately1) with a temporary prosthesis thatis not in functional occlusion, or2) when splinted together formultiple tooth replacement orwhen stabilized with anoverdenture supported by multipleimplants.	The NSI MAX ImplantSystem is intended forimplantation in themaxillary or mandibularmolar region where boneexists and the surgeon hasdetermined that theplacement of a narrowerdiameter implant wouldincrease the probability offailure due to poor primarystability, or increasedsurgical proceduresleading to complications.This MAX implant providessupport for fixed orremovable dentalprostheses in a singletooth, partially endentulousprostheses, or full archprostheses. It further addsthe option for immediateloading on single andsplinted multiple unitrestorations when goodprimary stability isachieved and withappropriate occlusalloading, to restore chewingfunction.
Design
Implant shape	Tapered	Tapered	N/A	N/A	Tapered	Tapered
Implant body diameter	7.0mm, 8.0mm	3.8mm, 4.6mm, 5.8mm	N/A	N/A	3.8mm, 4.6mm, 5.8mm	7mm, 8mm and 9mmdiameter
Implant length	7.5mm, 9.0mm, 10.5mm	7.5mm (except 3.8mm body),9mm, 10.5mm, 12mm, 15mm	N/A	N/A	7.5mm, 9.0mm, 10.5mm, 12.0mm.15mm	7.0mm, 9.0mm, 11.0mm
Outer thread	Buttress	Buttress	N/A	N/A	Reverse Buttress	V-thread
Surface	Implant - RBTCollar - Laser-Lok	Implant - RBTCollar - Laser-Lok	Anodize, TiN coating, Laser-Lok	Anodize, TiN coating, Laser-Lok	Implant - RBT, HACollar - Laser-Lok or Machined	Machined collar andblasted body
Connection	Internal Hex	Internal Hex	Internal Hex	Internal Hex	Internal Hex	External hex, Tri-Nex, IT(internal connection)
Internal thread	Spiralock UNF 1-72	Spiralock UNF 1-72	N/A	N/A	Spiralock UNF 1-72	V-thread - size unknown
Prosthetic platform	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	External hex: 5.0mm,6.0mm, 7.0mmTri-Nex: 5.0mm, 6.0mmIT (internal connection):4.8mm, 6.5mm
Material and Manufacturing
Implant Material	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Ti-6AI-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Titanium - grade unknown
Manufacturing process	Machined by BioHorizons or A-level supplier, surface treatedwith micro-machined grooves(Laser-Lok) and RBT	Machined by BioHorizons or A-level supplier, surface treatedwith micro-machined grooves(Laser-Lok) and RBT	Machined by BioHorizons or A-level supplier, select models aresurface treated with micro-machined grooves (Laser-Lok),TiN coating and anodized on thehex connection	Machined by BioHorizons or A-level supplier, select models aresurface treated with micro-machined grooves (Laser-Lok),TiN coating and anodized on thehex connection (except 3.0mmhex)	Machined by BioHorizons or A-level supplier, surface treated withmicro-machined grooves (Laser-Lok) and RBT	Unknown
Packaging	Tyvek-lidded blister tray(primary package), placedinside a tamper-evident outerbox (secondary package)	Tyvek-lidded blister tray(primary package), placedinside a tamper-evident outerbox (secondary package)	Poly/Tyvek pouch	Poly/Tyvek pouch	Tyvek-lidded blister tray	Unknown
Sterilization	25-40 kGy gamma irradiationdose range	25-40 kGy gamma irradiationdose range	N/A; abutments provided non-sterile for moist heat sterilization	N/A; abutments provided non-sterile for moist heat sterilization	25-40 kGy gamma irradiation doserange	Unknown

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Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.