(85 days)
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.
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.
The provided document is a 510(k) summary for the Nobel Biocare Adapter PS, which describes an implant/abutment system adapter. This type of document is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, the document does not contain any information regarding:
- A table of acceptance criteria and reported device performance: This document does not describe performance metrics or criteria that the device had to meet through testing.
- Sample size used for the test set and data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment or expert involvement is mentioned for performance evaluation.
- Adjudication method for the test set: Not applicable as no test set is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm-only) performance: This device is a physical dental component, not a software algorithm.
- Type of ground truth used: Not applicable as there's no performance study described.
- Sample size for the training set: Not applicable as there's no machine learning algorithm or training set.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory clearance for a dental device based on substantial equivalence and does not detail a study that proves the device meets specific performance acceptance criteria. It primarily focuses on the device description, indications for use, and a comparison to predicate devices for regulatory purposes.
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1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Herbert CraneDirector Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 5074 |
| Facsimile: | (714) 282-9023 |
| 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)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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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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§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)