Home GUDID D788152CC300101 CHIC
Primary DI D788152CC300101
Brand CHIC
Company Gc Orthodontics America Inc.
Model 15-2CC3-0010
Catalog number 15-2CC3-0010
Device description CHIC MINI Roth 022 U/L 5-5 HK 3
Published 2022-08-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name NJM Bracket, ceramic, orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NJM Bracket, Ceramic, Orthodontic Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D788152CC300101 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthodontic bracket, ceramic A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
Regulatory Flags# DUNS number 063167128 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07908611202772 CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA NJM 2026-05-26 07908611211422 KIT CERAMIC BRACKET ICERAM-P MBT 0.022 - 1 SET + TUBES + WIRES ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA NJM 2026-05-26 00190746198359 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198366 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198373 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198380 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198397 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198403 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198410 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198427 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198434 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198441 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198458 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198465 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198472 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198489 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198496 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198502 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198519 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198526 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198533 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198540 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198557 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198564 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198571 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198588 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198595 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198601 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198618 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23 00190746198625 Empower Clear Bracket AMERICAN ORTHODONTICS CORPORATION NJM 2026-03-23