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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 Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.4770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate
Third Party Review Not Third Party Eligible
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