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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.
 
DeviceCERASORB DENTAL
Generic NameBone grafting material, for dental bone repair
ApplicantCurasan AG
Lindigstrasse 4
Dkeinostheim D-63801
PMA NumberP800035
Supplement NumberS011
Date Received04/05/2002
Decision Date12/08/2003
Reclassified Date05/31/2005
Product Code LPK 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES, A TRADE NAME CHANGE, AND NEW MANUFACTURING SITES. THIS APPROVAL ALSO ACKNOWLEDGES THAT OWNERSHIP HAS BEEN TRANSFERRED FROM MITER, INC. TO CURASAN AG. CERASORB DENTAL WILL BE MANUFACTURED AT TWO NEW FACILITIES LOCATED AT CURASAN AG, GERMANY AND WILLY RUSCH AG, GERMANY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERASORB DENTAL AND IS INDICATED FOR DEFECTS AFTER EXTIRPATION OF DENTAL ALVEOLAR CYSTS; REPAIR OF MARGINAL AND PERIAPICAL PERIODONTAL ALVEOLAR BONY POCKETS AS WELL AS BIFURCATIONS AND TRIFURCATIONS OF THE TEETH; AUGMENTATION OF THE ATROPHIED ALVEOLAR RIDGE; ALVEOLAR AUGMENTATION OF MANDIBULAR AND MAXILLARY RIDGES; DEFECTS AFTER APICOECTOMY; AND FILLING BONE DEFECTS AFTER SURGICAL RESECTION OF IMPACTED TEETH (WITHOUT IMPLANTATION).
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