PROCERA ABUTMENT OCTAGON

K041275 · Nobel Biocare Uas, Inc. · NHA · May 27, 2004 · Dental

Device Facts

• Record ID: K041275
• Device Name: PROCERA ABUTMENT OCTAGON
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: NHA · Dental
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.

Device Story

Procera® Abutment Octagon is a prosthetic dental abutment; designed for permanent, long-term use; fits Straumann regular neck 4.8mm endosseous implants. Device restores chewing function in partially edentulous patients. Materials include titanium or zirconia. Used by dental professionals in clinical settings to support dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Prosthetic dental abutment; materials: titanium or zirconia; interface: Straumann regular neck 4.8mm endosseous implant; intended for permanent, long-term use.

Indications for Use

Indicated for partially edentulous patients requiring prosthetic restoration of chewing function using Straumann regular neck 4.8mm endosseous 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

• Esthetic Zirconia Abutment (K031719)
• TiAdapt Abutment System (K971706)
• ITI synOcta Meso Abutments (K033243)

Submission Summary (Full Text)

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041275
MAY
1. 4 510(k) Summary of Safety and Effectiveness

| Submitted by: | Elizabeth J. Mason<br>Sr. Regulatory Affairs Specialist |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | May 12, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Procera® Abutment Octagon |
| Legally Marketed Device(s): | Esthetic Zirconia Abutment (K031719)<br>TiAdapt Abutment System (K971706)<br>ITI synOcta Meso Abutments (K033243) |

## Device Description:

The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.

Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.

Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.

Indications for Use:

Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.

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## Performance Standards 1.5

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Glass if Opodar Ucharlor Dulanto Booknown Notertified as applicable to this submission.

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Public Health Service

MAY 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K041275

Trade/Device Name: Procera® Abutment Octagon Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 12, 2004 Received: May 12, 2004

Dear Ms. Mason:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinente, of to co, 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 contrely provision 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 Ecderal Register.

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## Page 2 -Ms. Mason

Please be advised that FDA's issuance of a substantial equivalence determination does not I foast that FDA has made a determination that your device complies with other requirements modi that 1 Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I odetar statues and sequirements, including, but not limited to: registration Tour must compry with a 807); labeling (21 CFR Part 801); good manufacturing practice alle histing (21 et retri in the quality systems (QS) regulation (21 CFR Part 820); and if requirements 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premarket notification - Free evice 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), 11 you don't be 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 may obtain 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/dsma/dsmamain.html

Sincerely yours,

Olin Liu, 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

Enclosure

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510(k) Number (if known):

K0412.75

Device Name: Procera® Abutment Octagon

Indications For Use:

Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous palients Novel Bloodie of Food as that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.

× 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 Rumps

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

510(k) Number:

Page 1 of 1

1.3

000007