NOBELACTIVE ZIRCONIA ABUTMENT

K072129 · Nobel Biocare AB · NHA · Feb 22, 2008 · Dental

Device Facts

• Record ID: K072129
• Device Name: NOBELACTIVE ZIRCONIA ABUTMENT
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Feb 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

NobelActive Zirconia 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 in the anterior region.

Device Story

NobelActive Zirconia Abutment is a pre-manufactured prosthetic component; connects directly to NobelActive endosseous dental implants. Used by dental clinicians for prosthetic rehabilitation in the anterior region. Design features internal hexagonal connection; functions as interface between implant and dental prosthesis. Device provides structural support for restorative tooth replacement. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Pre-manufactured zirconia dental abutment; internal hexagonal connection geometry; designed for NobelActive endosseous dental implants.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation in the anterior region 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

• SFB & CFB Angled Abutments (K062749)
• Esthetic Zirconia Abutment (K031719)

Submission Summary (Full Text)

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

| Submitted by: | Kam Leung, Ph.D., RAC<br>Senior Regulatory Affairs Specialist |
|----------------------------------------|------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7842 |
| Facsimile: | [phone] |
| Date of Submission: | August 1, 2007 |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | NobelActive Zirconia Abutment |
| Legally Marketed Device(s): | SFB & CFB Angled Abutments (K062749)<br>Esthetic Zirconia Abutment (K031719) |

## Device Description:

NobelActive Zirconia Abutments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous Esthetic Zirconia Abutments. The NobelActive Zirconia Abutments differ from the predicate device in trade name and material of construction.

### Indications for Use:

NobelActive Zirconia 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 in the anterior region.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, positioned to the right. Encircling the symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072129

Trade/Device Name: NobelActive Zirconia Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 8, 2008 Received: February 11, 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.

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# 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 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 (OS) 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,

Shea Runser

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

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# Indication for Use

510(k) Number (if known):

Device Name: NobelActive Zirconia Abutment

Indication For Use:

NobelActive Zirconia 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 in the anterior region.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 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 Quapp

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

Nobel Biocare Traditional 510(K) Not NobelActive Zirconia Abutment August 2007

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