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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, condyle, mandibular, temporary
Regulation Description Temporary mandibular condyle reconstruction plate.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNEI
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4770
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
Guidance Document
Third Party Review Not Third Party Eligible
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