FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040047934
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1014174
Catalog number
1014174
Device description
Margin Trimmer DE 28
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJZKnife, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040047934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040047934003040400479343040400479340304040047934

GMDN Terms#

Term, Definition table
TermDefinition
Margin finishing dental file/rasp, reusableA hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889950148003Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2026-02-24
10889950148010Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2026-02-24
07898506852307QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506854684QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506854929QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506854936QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506843664QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843671QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843701QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843718QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843732QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843954QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506847433QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506852291QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506852314QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506852321QuinelatoSchobell Industrial LtdaEJZ2022-12-08
10889950006433HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006440HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006457HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006464HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006471HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006488HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006495HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006501HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006518HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006525HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006532HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006549HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006556HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006570HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12