PMA P800035S011

Device: CERASORB DENTAL
Applicant: Curasan AG
PMA number: P800035
Supplement: S011
Product code: LPK
Decision date: 2003-12-08
Generic name: Bone grafting material, for dental bone repair
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).

Current openFDA PMA Record#

Device: CERASORB DENTAL
Applicant: Curasan AG
PMA number: P800035
Supplement: S011
Product code: LPK
Generic name: Bone grafting material, for dental bone repair
Decision date: 2003-12-08
Decision code: APPR
Date received: 2002-04-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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).