Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PERI-OSS |
Generic Name | Implant, endosseous, root-form |
Regulation Number | 872.3640 |
Applicant | CURASAN AG LINDIGSTRASSE 4 KLEINOSTHEIM D-638-6380 |
PMA Number | P800035 |
Supplement Number | S010 |
Date Received | 06/25/2001 |
Decision Date | 10/04/2001 |
Reclassified Date
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05/31/2005 |
Product Code |
DZE |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PERI-OSS AND IS INDICATED FOR REPAIR OF PERIODONTAL AND PERIAPICAL BONY DEFECTS. |
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