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U.S. Department of Health and Human Services

Product Classification

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Device bracket, plastic, orthodontic, reprocessed
Regulation Description Orthodontic plastic bracket.
Definition Same as dyw except it is being reprocessed.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNLC
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 872.5470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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