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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DevicePERI-OSS
Generic NameIMPLANT, ENDOSSEOUS, ROOT-FORM
Regulation Number872.3640
ApplicantCURASAN AG
LINDIGSTRASSE 4
KLEINOSTHEIM D-638-6380
PMA NumberP800035
Supplement NumberS010
Date Received06/25/2001
Decision Date10/04/2001
Reclassified Date 05/31/2005
Product Code DZE 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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