BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Restorative Components:

. Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.
Castable restorative components are intended for use as accessories to endosseous dental . implants to aid in the fabrication of dental prosthetics.
Screw componenets are intended for use as accessories to endosseous dental implants for . retention of screw retained abutments to the dental implant.

Device Description

The BIOMET 3i dental pre-formed and castable abutments and other restorative components consists of a variety of abutments, posts, cylinders and screws which are utilized to support the single and multiple tooth prostheses for either screw retained or cement retained restoration. These devices include appropriate features and dimensions to mate with BIOMET 3i dental implants cleared by K063341 and K063286 with either internal connections. The abutments may be used for single and multiple teeth.

AI/ML Overview

This 510(k) submission (K072642) for BIOMET 3i Dental Abutments and Restorative Components focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text for this device. The submission explicitly states:

"The modified BIOMET 3i dental pre-formed and castable abutments and other restorative components are equivalent to the predicate BIOMET 3i dental abutments and restorative components having the same intended uses, indications, technological characteristics, and principles of operation as the predicate device(s). The minor technological differences between the modified components and their predicate devices raise no new issues of safety or effectiveness. Thus, the modified dental abutments are substantially equivalent to their predicate devices."

This indicates that the manufacturer is demonstrating that their device is sufficiently similar to existing legally marketed devices, and thus does not require new primary performance data to prove safety and effectiveness.

Summary of what cannot be provided from this document:

A table of acceptance criteria and the reported device performance: Not applicable, as no new performance study with specific acceptance criteria and metrics is presented.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K072642

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510(k) SUMMARY

BIOMET 3i Dental Abutments & Restorative Components

Submitter	BIOMET 3i , Inc.4555 RiversidePalm Beach Gardens, FL 33410
Contact	Diana TaylorManager, Regulatory AffairsBIOMET 3i , Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6857Fax 561-776-6852
Date Prepared:	September 14, 2007
Name of Device:	BIOMET 3i Dental Abutments
Common or Usual Name	Dental Abutment
Classification Name	Abutment, implant, dental, endosseous
Classification	Class II21 CFR 872.3630
Product Code	NHA
Predicate Devices	UCLAGingehueCertain ProvidePre-Angled AbutmentsConical AbutmentsTapered AbutmentsTemporary Healing AbutmentsAbutment PostsRocket II AbutmentsIOL Abutments DEC 2 0 2007

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K072642

Intended Use / Indications for Use

Restorative Components:

. Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.
Castable restorative components are intended for use as accessories to endosseous dental . implants to aid in the fabrication of dental prosthetics.
Screw componenets are intended for use as accessories to endosseous dental implants for . retention of screw retained abutments to the dental implant.

Technological Characteristics

Substantial Equivalence

The modified BIOMET 3i dental abutments and restorative components are equivalent to the predicate BIOMET 3i dental abutments and restorative components having the same intended uses, indications, technological characteristics, and principles of operation as the predicate device(s). The minor technological differences between the modified components and their predicate devices raise no new issues of safety or effectiveness. Thus, the modified dental abutments are substantially equivalent to their predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

Ms. Diana Taylor Manager, Regulatory Affairs BIOMET 3i. Incorporated 4555 Riverside Road Palm Beach Gardens, Florida 33410

Re: K072642

Trade/Device Name: BIOMET 3i Dental Abutments and Restorative Components Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 3, 2007 Received: December 5, 2007

Dear Ms. Taylor:

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. Taylor

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,

Sura Quono
Chiu Lin, Ph.D.

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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K072642

BIOMET 3i™

Indications for Use

510(k) Number (if known):

Device Name: BIOMET 3i Dental Abutments and Restorative Components

Indications for Use:

Restorative Components

Temporary Healing Abutments are intended for use to shape and maintain . the soft tissue opening during healing.
. Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dental prosthetics.
. Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the dental implant.

[IDENTIFY WHETHER THE DEVICE IS INTENDED FOR PRESCRIPTION USE AND/OR OVER-THE-COUNTER USE.]

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

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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.)