BIOMET 31 Certain® Contoured Margin Ceramic Abutments are intended for use as an cessory to endosseous dental implants to support a prosthetic device in a partially or contains patient. The Certain® Contoured Margin Ceramic Abutments are intended for use support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is ment retained to the abutment.

Device Description

The BIOMET 3i Certain® Contoured Margin Ceramic Abutment design consists of The BIOME I 37 Certains Contoured in buttent screw. These devices worldwords ffferent abutments $125, thanimi insort and all about - 11.00 as 1000 as 1000 and and propriate reatures and 311 with internal connections.

AI/ML Overview

This 510(k) premarket notification is for a dental abutment, a mechanical device rather than an AI-powered one. Therefore, the questions regarding acceptance criteria, study details, ground truth, and training sets, which are typically relevant for AI/ML device submissions, do not apply here.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, as per the FDA's 510(k) pathway for medical devices that are not significantly new in technology or intended use.

Here's why the AI-specific questions are not applicable and what this document does provide:

No AI/ML Component: The device is a "Certain® Contoured Margin Ceramic Abutment," described as an accessory to endosseous dental implants. It's a physical component, not software with an algorithm.
No Device Performance Metrics (in the AI/ML sense): For mechanical devices like this, "performance" would typically refer to mechanical strength, biocompatibility, fit, etc., tested through benchmarks, fatigue tests, material characterization, or preclinical studies. The document states "minor technological differences between the proposed devices components and their predicate devices raise no new issues of safety or effectiveness," implying that standard tests were likely performed to confirm no degradation in these mechanical properties compared to the predicate, but specific performance metrics are not listed in this summary.
"Study" for 510(k) Substantial Equivalence: The "study" in this context is the comparison made by Biomet 3i to its own predicate device (BIOMET 3i Dental Ceramic Abutment) and a competitor's (Zimmer® Contour Ceramic Abutment). This comparison aims to show that the new device has the same intended use, indications, and technological characteristics, with no new issues of safety or effectiveness. This is a regulatory comparison, not a clinical trial or algorithm performance study.

Information provided in the document (relevant to a physical device submission):

Device Name: Certain® Contoured Margin Ceramic Abutment
Intended Use/Indications for Use: To support a prosthetic device in partially or completely edentulous patients, for single and multiple tooth prostheses in the mandible or maxilla, with the prosthesis cement-retained to the abutment.
Technological Characteristics: Described largely by its composition (Zirconium oxide material), connections (internal and external), and screw type.
Predicate Devices: BIOMET 3i Dental Ceramic Abutment and Zimmer® Contour Ceramic Abutment.
Substantial Equivalence Claim: The device has the "same general intended uses, indications, technological characteristics," and that "minor technological differences... raise no new issues of safety or effectiveness."

To answer the user's request for acceptance criteria and study information, I would have to state that these concepts as they relate to AI/ML devices are not applicable to the provided 510(k) summary for this mechanical dental component. The "acceptance criteria" here is simply satisfying the FDA's requirements for demonstrating substantial equivalence, and the "study" is the comparison against predicates.

Summary

{0}------------------------------------------------

Ko 73345

ROMET 31

MAR - 7 2008

510(k) SUMMARY

BIOMET 3i Contoured Margin Ceramic Abutment

BIOMET 3i, Inc.

Priscilla Caro

BIOMET 3i, Inc. Riverside Dr

Tel. 561-776-6785 Fax 561-514-6316

bmitter:

4555 Riverside Dr Palm Beach Gardens, FL 33410

Regulatory Affairs Specialist

Palm Beach Gardens, FL 33410

ntact Person:

ate Prepared:

ame of Device

rade/Proprietary Name: ommon/Usual Name

Slassification Name

assification

November 27, 2007

Certain® Contoured Margin Ceramic Abutment

Not available

Abutment, implant, dental, endosseous

Class II 21CFR 872.3630

oduct Code

edicate Devices

NHA

BIOMET 3i Dental Ceramic Abutment Zimmer® Contour Ceramic Abutment

tended Use / Indications for Use

{1}------------------------------------------------

echnological Characteristics

ubstantial Equivalence

The BIOMET 3i Certain® Contoured Margin Ceramic Abutments substantially equivalent o the BIOMET 37 Certain® Contouroum Margin Corants and Zimmer® Contour Ceramic of the predicate DrOWLY 37 Denat Condid uses, indications, technological characteristics, Abuttlent having the same general internets assoss, increased on the minor technological differences wetween the proposed devices components and their predicate devices raise no new issues of afety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

Ms. Priscilla Caro Regulatory Affairs Specialist Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K073345

Trade/Device Name: Certain® Contoured Margin Ceramic Abutment Regulation Number: 21 CFR 872,3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 29, 2008 Received: March 3, 2008

Dear Ms. Caro:

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. Caro

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvie Y. Mohano
md.

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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BOMET 31

cations for Use

Number (if known):

novice Name: Certain® Contoured Margin Ceramic Abutment

Hons for Use:

on BE 3i Certain® Contoured Margin Ceramic Abutments are intended for use as an to endosseous dental implants to support a prosthetic device in a partially or continus patient. The Certain® Contoured Margin Ceramic Abutments are intended for use to more single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is and retained to the abutment.

INFY WHETHER THE DEVICE IS INTENDED FOR PRESCRIPTION USE DOR OVER-THE-COUNTER USE.]

cription Use & 1 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ISE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumore

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

510(k) Number: K672245

Page

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.)