FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040051054
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9008106
Catalog number
9008106
Device description
Air Margin Trimmer 79/80
Published
2020-08-24
Public version status
Update
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
00304040051054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040051054003040400510543040400510540304040051054

GMDN Terms#

Term, Definition table
TermDefinition
Periotome, reusableA hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. 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