ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554

K063592 · Nobel Biocare AB · NHA · Feb 27, 2007 · Dental

Device Facts

• Record ID: K063592
• Device Name: ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Device Story

Adapter PS is a premanufactured dental prosthetic component; functions as an interface adapter between Nobel Biocare internal tri-lobe implants and hexed external connection abutments. Enables cross-platform compatibility: allows narrow platform hexed abutments on regular platform internal tri-lobe implants, and regular platform hexed abutments on wide platform internal tri-lobe implants. Used by dental professionals in clinical settings for prosthetic rehabilitation. Device facilitates secure connection between implant and abutment, aiding in patient tooth replacement and restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Premanufactured prosthetic component; mechanical adapter for dental implants. Facilitates connection between internal tri-lobe implant platforms and hexed external connection abutments. No software or electronic components.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. Used as a premanufactured prosthetic component connecting internal tri-lobe implants to hexed external connection abutments.

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)
• NobelReplace Adapter (K050444)

Submission Summary (Full Text)

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

| Submitted by: | Herbert Crane<br>Director Regulatory Affairs |
|-------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 5074 |
| Facsimile: | [phone] |
| Date of Submission: | December 1, 2006 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary or Model Name: | Adapter PS |
| Legally Marketed Device(s): | Esthetic Zirconia Abutment (K031719)<br>NobelReplace Adapter (K050444) |

## Device Description:

Nobel Biocare's Adapter PS is an implant/abutment system adapter. The Adapter PS allows a Nobel Biocare internal tri-lobe implant to be used with a hexed external connection abutment. The Adapter PS allows a narrow platform hexed abutment to be used on a regular platform internal tri-lobe implant and a regular platform hex abulment to be used on a wide platform internal tri-lobe implant. The Adapter PS may only be used with the implants and abutments listed in the Instructions For Use.

Indications for Use:

Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

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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 eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Herbert Crane Director, Regulatory Affairs Nobel Biocare AB l 5 Bohusgatan P.O. Box 5190 Goteborg, Sweden SE-402-26

FEB 2 7 2007

Re: K063592

Trade/Device Name: Adapter PS Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 12, 2007 Received: February 14, 2007

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.

Susan Dunne
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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## Indications for Use

510(k) Number (if known): KO 63592

Device Name: Adapter PS

Indications For Use:

Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is 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 Risses

State "College of the states FF (1987) (1) 488 ) (1) ്ന പ്രാവലംബം

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