FDA.reportPublic FDA data

Generic Buccal Tubes

Primary DI
00190746150265
Brand
Generic Buccal Tubes
Company
AMERICAN ORTHODONTICS CORPORATION
Model
48R
Catalog number
48R
Device description
DB TUBE PDS LR 3RD MOL 022 NON-CONV T-25 R7D W/HK
Published
2019-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

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
00190746150265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746150265001907461502651907461502650190746150265

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-558-7687info@americanortho.com
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746150012Superelastic Titanium Memory857-54138TQSPW857-54138TQSPW2019-08-12
00190746150029Superelastic Titanium Memory857-54234TQSPW857-54234TQSPW2019-08-12
00190746150036Superelastic Titanium Memory857-54238TQSPW857-54238TQSPW2019-08-12
00190746150098Superelastic Titanium Memory857-551TQSPW857-551TQSPW2019-08-12
00190746150104Superelastic Titanium Memory857-552TQSPW857-552TQSPW2019-08-12
00190746150128Superelastic Titanium Memory857-554TQSPW857-554TQSPW2019-08-12
00190746148354Superelastic Titanium Memory857-731W857-731W2019-08-09
00190746007835Procelain Conditioner001-966001-9662016-11-09
00190746133282Rapid Molar Intruder852-202852-2022018-07-05
00190746133299Rapid Molar Intruder852-203852-2032018-07-05
00190746096112MasterSeries390-8712B390-8712B2018-08-03
00190746096334MasterSeries390-8713B390-8713B2018-08-03
00190746097904MasterSeries390-8716B390-8716B2018-08-03
00190746098093MasterSeries390-8717B390-8717B2018-08-03
00190746203770Weldable Cleat852-166852-1662026-04-21
00190746203787Weldable Cleat852-166PK852-166PK2026-04-21
00190746203794Weldable Cleat852-168PK852-168PK2026-04-21
00190746203800Weldable Cleat852-168852-1682026-04-21
00190746203817Weldable Cleat852-167PK852-167PK2026-04-21
00190746203824Weldable Cleat852-167852-1672026-04-21

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