SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM

K062749 · Nobel Biocare AB · NHA · Nov 29, 2006 · Dental

Device Facts

• Record ID: K062749
• Device Name: SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prostheit rehabilitation.

Device Story

SFB and CFB Angled Abutments are premanufactured prosthetic components for dental restoration; designed to connect directly to SFB and CFB endosseous dental implants. Angled design provides increased flexibility during implant placement and prosthetic rehabilitation compared to straight abutments. Used by dental professionals in clinical settings to support artificial teeth. Device facilitates restoration process by allowing for angulation adjustments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Premanufactured prosthetic components for endosseous dental implants (21 CFR 872.3630). Angled form factor for improved placement flexibility. Connects directly to SFB/CFB implant systems.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. Used as premanufactured prosthetic components connected to SFB & CFB 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

• SFB & CFB Implants (K061003)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a combination of letters and numbers, along with a date. The alphanumeric string "K062749" is prominently displayed in a bold, handwritten style. Above this string, the date "NOV 29 2006" is printed in a smaller, sans-serif font, indicating a specific date in November 2006.

## 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Ms. Phuong Nguyen Son<br>Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | September 13, 2006 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | SFB & CFB Angled Abutments |
| Legally Marketed Device(s): | SFB & CFB Implants (K061003) |

## Device Description:

Nobel Biocare's SFB and CFB angled abutments are artificial tooth abutments designed to fit and function on the SFB and CFB implants. SFB and CFB angled abutments differ from the predicate SFB and CFB abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.

## Indications for Use:

Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prostheit rehabilitation.

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

Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

NOV 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Herbert Crane Director, Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K062749

Trade/Device Name: SFB & CFB Angled Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: September 13, 2006 Received: September 14, 2006

Dear Mr. Crane:

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 - Mr. Crane

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 yours,

Suva Runge
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

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

K062749

## Indications for Use

510(k) Number (if known):

Device Name: SFB & CFB Angled Abutments

Indications For Use:

Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

× 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 Runge

masthestology, General Huspitz.i ontrol, Dental Devi

Page 1 of 1