BioHorizons Tapered Internal Plus 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

BioHorizons Tapered Internal Plus Implants are machined titanium, screw-form endosseous dental implants supplied in 3.8mm, 4.6mm and 5.8mm diameters across lengths of 7.5mm (except 3.8mm diameter), 9mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, to 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 text describes a 510(k) summary for the BioHorizons Tapered Internal Plus Implants. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, independent device performance.

Therefore, many of the requested categories related to clinical study design, AI performance, expert review, and ground truth are not applicable to this type of regulatory submission. The document relies on mechanical testing to show equivalence, not clinical effectiveness studies as might be found for more complex medical devices, especially those involving AI/ML.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from equivalence claim)	Reported Device Performance (from "Summary of Testing")
Substantial equivalence to predicate device in terms of performance, safety, and effectiveness.	Fatigue Load Testing: Results demonstrate substantial equivalence to predicate devices (in conjunction with both straight and angled prosthetic abutments).
	Insertion Torque Testing: 3.0mm implant level driver can fully seat 3.8mm Tapered Internal Plus implants in all bone densities without loss of function of implant hex or driver hex. Average insertion torque: 214.4 Ncm.

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

Sample Size: Not explicitly stated for each test (fatigue or insertion torque). Mechanical testing typically uses a small, statistically relevant number of samples for each size/configuration.
Data Provenance: The document implies the testing was performed internally by BioHorizons or a contracted lab, as it refers to "the subject devices" and "this submission." No specific country of origin is mentioned beyond the manufacturer's location (Birmingham, AL, USA). The data is generated as part of a regulatory submission, which is prospective in the sense of demonstrating performance for a new product, but not a prospective clinical trial.

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

Not Applicable. This is a mechanical engineering study, not a clinical study involving human assessment or interpretation where experts would establish ground truth for a test set in the conventional sense (e.g., radiologists for imagery). The "ground truth" here is the physical performance of the device against established engineering standards (ISO 14801).

4. Adjudication Method for the Test Set

Not Applicable. See point 3. This is not a study where human adjudication of results/diagnoses would be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is not a study involving human readers or comparative effectiveness in a clinical setting. It's a mechanical testing report for hardware.

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

Not Applicable. This device is a physical dental implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

Physical Performance Against Standards: The ground truth for this submission is the objective measurement of mechanical properties (fatigue strength, insertion torque) as compared to:
- The performance of the predicate device.
- Established industry standards like ISO 14801.
- Guidance documents such as the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. See point 8.

Summary

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SEP 5 2012

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, Regulatory Affairs Manager
Date prepared:	August 3, 2012

Name of the Device

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

Predicate Device

1. BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007.

Device Description

Intended Use

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Technological Characteristics

The fundamental scientific technology of the BioHorizons Tapered Internal Plus endosseous dental implant devices subject to this 510(k) is substantially equivalent to the referenced 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.

All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Tapered Internal Implant System (K071638), and the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Implant System. The BioHorizons Tapered Internal Plus Implants are substantially equivalent to the features of the predicate implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use.

Summary of Testing

Mechanical testing was performed on the subject devices 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. The devices were tested in conjunction with both straight and angled prosthetic abutments. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.

Insertion torque testing performed on the subject devices demonstrates that the 3.0mm implant level driver can fully seat the 3.8mm Tapered Internal Plus implants in all bone densities without loss of function of the implant hex or the driver hex with an average insertion torque of 214.4 Nom.

Conclusion

The data presented in this submission demonstrates that the new devices are substantially equivalent with respect to performance, safety and effectiveness for their intended use and perform as well as the referenced predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

BioHorizons Implant Systems, Incorporated Mr. Michael Davis Regulatory Affairs Manager 2300 Riverchase Center Birmingham, Alabama 35244

SEP 5 2012

Re: K121787

Trade/Device Name: BioHorizons Tapered Internal Plus Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 3, 2012 Received: August 6, 2012

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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Page 2- Mr. Davis

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

. 510(k) Number: K120787

Device Name: BioHorizons Tapered Internal Plus Implants

Indications for Use:

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)

Susan Rosser

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anestheolorology.
Infection Control, Dental Devices

Infection Control #:

510(k) Number: K121787

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.