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U.S. Department of Health and Human Services

Product Classification

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Device bone grafting material, for dental bone repair
Regulation Description Bone grafting material.
Definition Tricalcium phosphate bone grafting material
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeLPK
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3930
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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