Home GUDID D8199013332 OnBrace Crown LR3 (5/pk)
Primary DI D8199013332
Brand OnBrace Crown LR3 (5/pk)
Company SPECIALTY APPLIANCES, LLC
Model 901333
Published 2024-03-08
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 true Product Codes# Code, Name table Code Name ECM Band, Preformed, Orthodontic ELZ Crown, Preformed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ECM Band, Preformed, Orthodontic Dental 1 ELZ Crown, Preformed Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D8199013332 Package HIBCC 5 In Commercial Distribution D8199013330 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Preformed dental crown, temporary A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.
Regulatory Flags# DUNS number 106645484 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 true Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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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