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510(k) Data Aggregation
K Number
K033110Device Name
C-GRAFT
Manufacturer
Date Cleared
2003-12-10
(71 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
THE CLINICIAN'S PREFERENCE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
C-GRAFT™ is indicated for:
- Augmentation of bony defects of the alveolar ridge
- Sinus elevation grafting
- Treatment of intrabony periodontal defects
- Extraction socket grafting
Device Description
C-GRAFT™ is a bone filling and augmentation matcrial indicated for use in dental applications. C-GRAFT™ is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted red sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. C-GRAFT™ is provided sterile in pre-filled vials and has a granule size range from 300-1000 microns.
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