Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:

AstraTech 3.5, 4.0, 4.5, 5.0 mm
Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Ankylos 3.5, 4.5, 5.5, 7.0 mm

Device Description

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

AstraTech 3.5, 4.0, 4.5, 5.0 mm -
-Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
. Ankylos 3.5, 4.5, 5.5, 7.0 mm
The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

AI/ML Overview

The provided text is a 510(k) Summary for a dental abutment device. It outlines the device description, indications for use, and a letter from the FDA confirming substantial equivalence. However, it does not include information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

Summary

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

510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Ms. Phuong Nguyen SonRegulatory Affairs Specialist	AUG 11 2006
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 7830
Facsimile:	(714) 282-9023
Date of Submission:	May 26, 2006
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	Multi-Unit Abutments for AstraTech, Camlog, and Ankylos Implant Systems
Legally Marketed Device(s):	Brånemark System Abutments Complete (K925769)AstraTech Fixture MicroThread OsseoSpeed (K053384)Altatec Camlog Screwline Implant System (K022425)Ankylos Dental Implant System (K041509)

Device Description:

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

AstraTech 3.5, 4.0, 4.5, 5.0 mm -
-Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
. Ankylos 3.5, 4.5, 5.5, 7.0 mm

The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.

Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

Indications for Use:

-AstraTech 3.5, 4.0, 4.5, 5.0 mm
-Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Ankylos 3.5, 4.5, 5.5, 7.0 mm -

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

Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

AUG 1 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K061477

Trade/Device Name: Multi-Unit Abutments for AstraTech, Camlog and Anklos Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 26, 2006 Received: May 30, 2006

Dear Ms. Nguyen Son:

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.

{2}------------------------------------------------

Page 2 - Ms. Nguyen Son

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.

Susan Raaser
f. Chi-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

{3}------------------------------------------------

Indications for Use

K061477 510(k) Number (if known):

Device Name: Multi-Unit Abutments for AstraTech, Camlog and Ankylos Implant Systems

Indications For Use:

AstraTech 3.5, 4.0, 4.5, 5.0 mm
Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Ankylos 3.5, 4.5, 5.5, 7.0 mm

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

Page 1 of 1

...n Sign-Cit)
Han of Anesthesiology, General Hospital,
เอก Control, Dental Devices
Number: Kd6M77

1.3

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.)