FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040049259
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1066184
Catalog number
1066184
Device description
Bracket Forcep Anterior
Published
2019-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ECQALIGNER, BRACKET, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040049259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040049259003040400492593040400492590304040049259

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194403439AiraAIRA, LLCECQ2026-08-26
G859PT20260010Clear Moves AlignerCLEAR MOVES ALIGNERSECQ2026-05-22
G149TBSB1240TBS BASICSACME ENTERPRISE.ECQ2026-05-20
G149TBSB1250TBS BASICSACME ENTERPRISE.ECQ2026-05-20
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaECQ2026-02-10
D90970000913ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097000111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001011ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001021ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970010M1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011511ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011713ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700117L1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011814ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011915ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700119S1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970012310ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970013210ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
00371347018332Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00371347018349Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00723896026847SMILEGOODS ALIGNER CHEWIES MINT 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026854SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026878SMILEGOODS ALIGNER CHEWIES MINT PRACTICON, INC.ECQ2024-08-07
00723896026885SMILEGOODS ALIGNER CHEWIES UNSCENTED PRACTICON, INC.ECQ2024-08-07
00723896026892SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026908SMILEGOODS ALIGNER CHEWIES ASSORTED PRACTICON, INC.ECQ2024-08-07
D90946300111ECLIPSE PASSIVE Ortho Arch Company IncECQ2023-06-20
D90946161116ECLIPSE INTERACTIVEOrtho Arch Company IncECQ2023-06-14
D909270106103LINGUAL BUTTON Ortho Arch Company IncECQ2023-06-13