The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.

The BioHorizons Tapered Internal Implant System may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion or
1. when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Device Description

BioHorizons Tapered Internal Implant System is a system of tapered, threaded, internal connection, root form implants and matching abutments 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 external design of the implant is the same as that of the Bio-Lok Implant System, including the Laser-Lok® collar. The internal connection and the platform are the same as those of the BioHorizons Prodigy System™ Endosseous Implants.

AI/ML Overview

The provided 510(k) summary for the "BioHorizons Tapered Internal Implant System" (K071638) does not describe any specific acceptance criteria for performance or a study demonstrating the device meets such criteria.

Instead, this document focuses on establishing substantial equivalence to predicate devices already on the market. This means the device is being presented as being as safe and effective as a legally marketed device, rather than providing novel performance data for specific criteria.

Therefore, most of the requested information cannot be extracted from this document because the regulatory pathway chosen (substantial equivalence) does not typically require the type of detailed performance criteria and study results you are asking for (e.g., sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, etc.).

Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:

Description of Acceptance Criteria and Proving Device Meets Criteria

No specific acceptance criteria for device performance are mentioned in this document. The primary "acceptance criterion" for this 510(k) submission is that the device is substantially equivalent to legally marketed predicate devices.

No study proving the device meets specific acceptance criteria is described in this document. The document asserts that "BioHorizons Implants Systems, Inc. demonstrated that... the BioHorizons Tapered Internal Implant System is substantially equivalent in indications and design principles to predicate devices." This demonstration would likely involve comparisons of design, materials, and intended use, rather than a clinical performance study with defined criteria and outcomes.

Requested Information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in this document. The "acceptance" is based on substantial equivalence to predicate devices, not on defined performance metrics.
Reported Device Performance: Not reported in this document. Performance is implicitly assumed to be similar to the predicate devices due to substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/not provided. No specific test set for performance evaluation is described.
Data Provenance: Not applicable/not provided.

3. 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/not provided. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not provided. No adjudication method for a test set is described.

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 device is a dental implant system, not an AI-powered diagnostic tool, so MRMC studies and AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/not provided. Ground truth for performance is not discussed as no performance study is detailed.

8. The sample size for the training set

Not applicable/not provided. No training set for an algorithm is described.

9. How the ground truth for the training set was established

Not applicable/not provided. No training set or ground truth establishment for it is described.

Summary of Device and Regulatory Context (from the document):

Device Name: BioHorizons Tapered Internal Implant System
Intended Use: Artificial root structure for single tooth replacement, fixed bridgework, and dental retention in the mandible or maxilla. Can be immediately restored with a temporary prosthesis (not in functional occlusion) or when splinted/stabilized with an overdenture.
Device Description: Tapered, threaded, internal connection, root form implants with matching abutments. External design (including Laser-Lok® collar) is like the Bio-Lok Implant System. Internal connection and platform are like the BioHorizons Prodigy System™ Endosseous Implants.
Classification: Class II (Endosseous dental implant, 21 CFR 872.3640; Endosseous dental implant abutment, 21 CFR 872.3630).
Regulatory Pathway: 510(k) premarket notification based on substantial equivalence to predicate devices. This means the device is considered "as safe and effective" as devices already legally marketed, rather than requiring novel clinical performance data that would specify acceptance criteria and study results.

Summary

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510(k) Summary

K071638

BioHorizons Implant Systems, Inc. BioHorizons Tapered Internal Implant System

007 10 2007

ADMINISTRATIVE INFORMATION

Manufacturer Name:	BioHorizons Implant Systems, Inc.One Perimeter Park South, Suite 230 SouthBirmingham, AL 35243 USATelephone 1 (205) 967-7880Fax 1 (205) 870-0304
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Official Contact:

Winston Greer

Representative/Consultant:

Linda Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone 1 (858) 792-1235 : Fax 1 (858) 792-1236 email: lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	BioHorizons Tapered Internal Implant System
Common Name:	Dental implants and abutments
Classification Regulations:	Endosseous dental implant(21 CFR 872.3640), Class IIEndosseous dental implant abutment(21 CFR 872.3630), Class II
Product Codes	DZE, NHA

DEVICE CLASSIFICATION PANEL

The Classification Panel for these devices is the Dental Products Panel, and they are reviewed by the Dental Devices Branch.

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INTENDED USE

The BioHorizons Tapered Internal Implant System may be restored immediately

l ) with a temporary prosthesis that is not in functional occlusion or

when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

BioHorizons Implants Systems, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the BioHorizons Tapered Internal Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices,

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized graphic. The graphic consists of three abstract shapes that resemble human figures or flowing lines, stacked on top of each other.

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioHorizons Implant Systems, Incorporated C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 EL Camino Real, Suite 200 San Diego, California 92130

Re: K071638

Trade/Device Name: BioHorizons Tapered Internal Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 26, 2007 Received: September 27, 2007

Dear Ms. Schulz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Schulz

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syitte y. Michael Omd.

Chiu Lin. Ph.D. 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 (if known): KD 71633

Device Name:

BioHorizons Tapered Internal Implant System

Indications for Use:

The BioHorizons Tapered Internal Implant System may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion or
1. when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)


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

510(k) Number:	K071638
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Page 1 of ______15 of 336

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.