TITANIUM SCALLOPED ABUTMENT

K063768 · Vident · NHA · Jun 27, 2007 · Dental

Device Facts

• Record ID: K063768
• Device Name: TITANIUM SCALLOPED ABUTMENT
• Applicant: Vident
• Product Code: NHA · Dental
• Decision Date: Jun 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium Scalloped abutments are designed for use with Nobel Biocare® Brånemark™ external hex, 3i™ external hex and Zimmer® internal hex dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,

Device Story

Titanium Scalloped Abutment serves as a dental implant substructure; interfaces with Nobel Biocare Brånemark, 3i, and Zimmer implant systems. Device seats directly onto implant body; supports cemented prosthetic restorations. Used in dental clinics by licensed practitioners for full arch or partial edentulous patient rehabilitation. Provides structural connection between endosseous implant and final prosthesis; facilitates functional and aesthetic tooth replacement.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Titanium. Form factor: Scalloped abutment designed for external/internal hex dental implant interfaces. Function: Mechanical substructure for cemented prostheses. Non-osseointegrating.

Indications for Use

Indicated for full arch or partially edentulous patients requiring dental restoration, including single implant restorations, using compatible Nobel Biocare Brånemark, 3i, or Zimmer dental implant systems.

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.)

Submission Summary (Full Text)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text is black against a white background.

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." arranged in a circular pattern around the eagle. The eagle is depicted with stylized lines, giving it a modern and symbolic appearance. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2007

Ms. Elizabeth Wolfsen Regulatory Affairs Specialist VIDENT 3150 East Birch Street P.O. Box 2340 Brea, California 92822-2340

Re: K063768

Trade/Device Name: Titanium Scalloped Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: April 3, 2007 Received: April 9, 2007

Dear Ms. Wolfsen:

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.

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

## Page 2 -Ms. Wolfsen

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suste 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

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

## Indications for Use

510(k) Number (if known): K063768

Titanium Scalloped Abutment Device Name:

Indications For Use: The Titanium Scalloped abutments are designed for use with Nobel Biocare® Brånemark™ external hex, 31™ external hex and Zimmer® internal hex dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

inesthesiolog Intection Control, Denta

510(k) Number: K963268

Page 1 of 1