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510(k) Data Aggregation
K Number
K101718Device Name
OSSEOCONDUCT
Date Cleared
2010-10-26
(130 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OsseoConduct is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including ridge augmentation, sinus lifts, craniofacial augmentation, filling of defects of endodontic origin, filling of cystic defects, filling of extraction sites, filling of lesions of periodontal origin, repair of traumatic defects of the alveolar ridge, filling of resection defects from bone tumors, cysts or other osseous defects, and a substitute for autogenous or allogenic bone grafts.
Device Description
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