FDA.reportPublic FDA data

Buccal Tubes

Primary DI
00190746084577
Brand
Buccal Tubes
Company
AMERICAN ORTHODONTICS CORPORATION
Model
955-067CR
Catalog number
955-067CR
Device description
DB TUBE LR 1ST MOL 022 NON-CONV T-20 R=0 4.2MM W/HK
Published
2017-11-30
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
00190746084577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746084577001907460845771907460845770190746084577

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
07908611204158ICERAM CERAMIC BUTTON FOR BONDING - 2UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611204172ICERAM CERAMIC BUTTON FOR BONDING - 10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207715BONDING TUBE MJANSON MBT 0,022 -SINGLE/N CONVERTIBLE U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207722MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE U7R (17) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207739BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207746MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE U7L (27) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207753BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207760MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE L7L (37) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207777BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207784MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE L7R (47) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207791BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE U6R (16) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207807BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE U6L (26) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207814BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE L6L (36) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207821BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE L6R (46) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207838MINI TUBE UNIVERSAL MJANSON MBT 0.022 - BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207999KIT BONDING TUBES ADVANCED MBT 0.022 - 200UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
00190746197116Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197123Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197130Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197147Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197154Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197161Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197178Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197185Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197192Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197208Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197215Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197222Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197239Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197246Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23