FDA.reportPublic FDA data

022x028 AW Tubes-R

Primary DI
D8199000000
Brand
022x028 AW Tubes-R
Company
SPECIALTY APPLIANCES, LLC
Model
900000
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8199000005PackageHIBCC10In Commercial Distribution
D8199000000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is 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 DIBrandModelCatalogPublished
D81990023903-Part TS Herbst Kit9002392022-11-21
D81990024004-Part Telescoping Herbst Replacement Parts9002402022-11-21
D8199002410Traditional Herbst Replacement Parts9002412022-11-21
D8199512450G4 NiTi Lingual Wire .010 Small Upper9512452025-07-18
D8199512460G4 NiTi Lingual Wire .010 Small Lower9512462025-07-18
D8199512470G4 NiTi Lingual Wire .010 Medium Upper9512472025-07-18
D8199512480G4 NiTi Lingual Wire .010 Medium Lower9512482025-07-18
D8199512490G4 NiTi Lingual Wire .010 Large Upper9512492025-07-18
D8199512500G4 NiTi Lingual Wire .010 Large Lower9512502025-07-18
D8199512510G4 NiTi Lingual Wire .013 Small Upper9512512025-07-18
D8199512520G4 NiTi Lingual Wire .013 Small Lower9512522025-07-18
D8199512530G4 NiTi Lingual Wire .013 Medium Upper9512532025-07-18
D8199512540G4 NiTi Lingual Wire .013 Medium Lower9512542025-07-18
D8199512550G4 NiTi Lingual Wire .013 Large Upper9512552025-07-18
D8199512560G4 NiTi Lingual Wire .013 Large Lower9512562025-07-18
D8199512570G4 NiTi Lingual Wire .016 Small Upper9512572025-07-18
D8199512580G4 NiTi Lingual Wire .016 Small Lower9512582025-07-18
D8199512590G4 NiTi Lingual Wire .016 Medium Upper9512592025-07-18
D8199512600G4 NiTi Lingual Wire .016 Medium Lower9512602025-07-18
D8199512610G4 NiTi Lingual Wire .016 Large Upper9512612025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611212702BONDING TUBE PREMIUM ROTH 0.018 - U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213556BONDING TUBE PREMIUM ROTH 0.018 - U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213587BONDING TUBE PREMIUM ROTH 0.018 - L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213839BONDING TUBE PREMIUM ROTH 0.018 - L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
10190886052952AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052969AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052976AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052983AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052990AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053003AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053010AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053027AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053034AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053041AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053058AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053065AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053072AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053089AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053096AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053102AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053119AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053126AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053133AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053140AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053157AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053164AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053171AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053188AGILITYG & H Wire Company, Inc.DZD2025-03-27