GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP

K083100 · Nobel Biocare USA, LLC · NHA · Nov 19, 2008 · Dental

Device Facts

• Record ID: K083100
• Device Name: GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
• Applicant: Nobel Biocare USA, LLC
• Product Code: NHA · Dental
• Decision Date: Nov 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. Nobel Blocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Device Story

NobelActive GoldAdapt Abutment is a gold alloy prosthetic component for the NobelActive dental implant system. It connects directly to the endosseous implant to support artificial teeth. Used by dental clinicians in a clinical setting to restore patient esthetics and chewing function. The device is available in engaging and non-engaging styles to accommodate different prosthetic needs. It facilitates the rehabilitation of edentulous sites by providing a stable interface between the implant and the final prosthesis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gold alloy endosseous dental implant abutment. Available in engaging and non-engaging configurations. Designed for use with NobelActive internal connection implants.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple unit dental restorations in the upper or lower jaw. Implants may be placed immediately and put into immediate function if initial stability requirements are met.

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

• NobelActive Internal Connection Implant (K071370)
• Auradapt Abutment System (K972475)
• NobelActive Zirconia Abutment (K072129)

Submission Summary (Full Text)

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

K083100

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

| Submitted by: | Herbert Crane<br>Director, Global Regulatory Affairs | NOV 19 2008 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Date of Submission: | October 17, 2008 | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Trade or Proprietary<br>or Model Name: | NobelActive GoldAdapt Abutment with Screw | |
| Legally Marketed Devices: | Nobel Biocare - NobelActive Internal Connection Implant (K071370)<br>Nobel Biocare - Auradapt Abutment System (K972475)<br>Nobel Biocare - NobelActive Zirconia Abutment (K072129) | |

### Device Description:

The NobelActive GoldAdapt Abutment is an endosseous dental implant abutment intended to be used with the NobelActive implant system. The NobelActive GoldAdapt is made of gold alloy and comes in engaging and non-engaging styles.

NobelActive Internal Connection Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

### Indications for Use:

NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Nobel Blocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare Special 510(k) Notification NobelActive GoldAdapt Abutment October 2008

000012

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2008

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

Re: K083100

Trade/Device Name: NobelActive GoldAdapt Abutment, NobclActive Internal Connection Implant Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Il Product Code: NHA, DZE Dated: October 17, 2008 Received: October 20, 2008

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 complies with other requirements of the Act or any l'ederal 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Smite Y. Michael Jmd

Chief of Staff, Ph.D. FOR DR CHUE UN

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):

Device Name: NobelActive Internal Connection Implant

Indications For Use:

Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and rhewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

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 Lynn

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

000007

10(k) Number:

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: NobelActive GoldAdapt Abutment

Indications For Use:

NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an an in 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 Kumpe

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K25324

Page 1 of 1

000011