21 CFR 872.5470 — Bracket, Plastic, Orthodontic

Dental (DE) · Subpart F—Therapeutic Devices · § 872.5470

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DYWBracket, Plastic, Orthodontic2423rd Party
NJMBracket, Ceramic, Orthodontic2603rd Party
NLCBracket, Plastic, Orthodontic, Reprocessed203rd Party
NXCAligner, Sequential2143SaMD, 3rd Party
OYHOrthodontic Vibratory Accessory253rd Party
PLHOrthodontic Led Accessory22SaMD, 3rd Party
PNNOrthodontic Software233SaMD, 3rd Party
Innolitics

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