Home GUDID D807100132101 IN-OVATION® C
Primary DI D807100132101
Brand IN-OVATION® C
Company DENTSPLY SIRONA ORTHODONTICS INC.
Model 100-132-10
Catalog number 100-132-10
Device description IN-OVATION® C Base Rx 022/UR3 -2T 13A4MHK
Published 2017-06-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true 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 D807100132101 Primary HIBCC 0 D807100132100 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Self-ligating orthodontic bracket 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 has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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 116903307 Device count 5 DM exempt true Premarket exempt false 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 true 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
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