Home GUDID D8199014040 Pedo OnBrace Crown UL4 (5/pk)
Primary DI D8199014040
Brand Pedo OnBrace Crown UL4 (5/pk)
Company SPECIALTY APPLIANCES, LLC
Model 901404
Published 2024-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name ECM Band, Preformed, Orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ECM Band, Preformed, Orthodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D8199014042 Package HIBCC 5 In Commercial Distribution D8199014040 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthodontic metal band A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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 106645484 Device count 1 Premarket exempt true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D8199002390 3-Part TS Herbst Kit 900239 2022-11-21 D8199002400 4-Part Telescoping Herbst Replacement Parts 900240 2022-11-21 D8199002410 Traditional Herbst Replacement Parts 900241 2022-11-21 D8199512450 G4 NiTi Lingual Wire .010 Small Upper 951245 2025-07-18 D8199512460 G4 NiTi Lingual Wire .010 Small Lower 951246 2025-07-18 D8199512470 G4 NiTi Lingual Wire .010 Medium Upper 951247 2025-07-18 D8199512480 G4 NiTi Lingual Wire .010 Medium Lower 951248 2025-07-18 D8199512490 G4 NiTi Lingual Wire .010 Large Upper 951249 2025-07-18 D8199512500 G4 NiTi Lingual Wire .010 Large Lower 951250 2025-07-18 D8199512510 G4 NiTi Lingual Wire .013 Small Upper 951251 2025-07-18 D8199512520 G4 NiTi Lingual Wire .013 Small Lower 951252 2025-07-18 D8199512530 G4 NiTi Lingual Wire .013 Medium Upper 951253 2025-07-18 D8199512540 G4 NiTi Lingual Wire .013 Medium Lower 951254 2025-07-18 D8199512550 G4 NiTi Lingual Wire .013 Large Upper 951255 2025-07-18 D8199512560 G4 NiTi Lingual Wire .013 Large Lower 951256 2025-07-18 D8199512570 G4 NiTi Lingual Wire .016 Small Upper 951257 2025-07-18 D8199512580 G4 NiTi Lingual Wire .016 Small Lower 951258 2025-07-18 D8199512590 G4 NiTi Lingual Wire .016 Medium Upper 951259 2025-07-18 D8199512600 G4 NiTi Lingual Wire .016 Medium Lower 951260 2025-07-18 D8199512610 G4 NiTi Lingual Wire .016 Large Upper 951261 2025-07-18
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