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U.S. Department of Health and Human Services

Product Classification

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Device materials, polytetrafluoroethylene vitreous carbon, for maxillofacial alveolar ridge augmentation
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNFE
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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