LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION

K092341 · Biomet 3i, Inc. · NHA · Nov 30, 2009 · Dental

Device Facts

• Record ID: K092341
• Device Name: LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION
• Applicant: Biomet 3i, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants 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 is screw retained to the abutment.

Device Story

Low Profile Abutment functions as a mechanical interface between an endosseous dental implant and a prosthetic device. Used in dental clinics by practitioners to support single or multiple tooth restorations. The abutment is secured to the implant, and the prosthesis is screw-retained to the abutment. Provides structural support for dental restorations in edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutment. Mechanical interface component. Dimensions and form factor designed for low-profile prosthetic support. Materials and sterilization methods consistent with standard dental implant abutment practices.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthesis support in the mandible or maxilla via endosseous dental implants.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Conical Abutments (Straight and Angled)
• Immediate Occlusal Loading (IOL) Abutments
• Asyst Abutment

Submission Summary (Full Text)

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K092341

Traditional 510(k) Pre-market Notification - Low Profile Abutment

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## 510(k) Summary

NOV 3 0 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

1038806

July 27th, 2009

Delivery Device

Submitter:

Biomet 3i

BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410

Establishment Registration Number: Contact:

Jose E. Cabrera Sr. Manager, Regulatory Affairs BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 Tel. [phone] Fax. [phone] Email [e-mail]

Trade/Proprietary Name: N/A

Common/Usual Name: Low Profile Abutment

Abutment, implant, dental, endosseous Classification Name:

Class II - 21 CFR \$872.3630 / NHA Device Classification/Code:

Predicate Device:

Date Prepared:

Indications for Use:

BIOMET 3i Low Profile 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 is screw retained to the abutment.

Conical Abutments (Straight and Angled), Immediate

Occlusal Loading (IOL) Abutments, Asyst Abutment

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Jose E. Cabrera Senior Medical, Regulatory Affairs Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

NOV 3 0 2009

Re: K092341

Trade/Device Name: Low Profile Abutment Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 17, 2009 Received: November 18, 2009

Dear Mr. Cabrera:

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 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. Cabrera

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

N for

Susan Runner, D.D.S., M.A. Acting Division 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):

Device Name: Low Profile Abutment

Indications for Use:

BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants 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 is screw retained to the abutment.

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 OF NEEDED)

> Concurrence of CDRH, Office of Device Evaluation (ODE) Br. Kerin Thur D850

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- 510(k) Number: K09234