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U.S. Department of Health and Human Services

Product Classification

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Device bone grafting material, human source
Regulation Description Bone grafting material.
Definition Intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects.These defects may be surgically creatd osseous defects or osseous defects created from traumatic injry to the bone, inlcuding periodenta/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNUN
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.3930
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible