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U.S. Department of Health and Human Services

Product Classification

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Device bracket, ceramic, orthodontic
Regulation Description Orthodontic plastic bracket.
Definition An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new postion.(the current classification only specifies plastic brackets.Confusion exists as to whether ceramic brackets are regulated.).
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNJM
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
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons