FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040047552
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1011537
Catalog number
1011537
Device description
Margin Trimmer DE 29
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00304040047552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040047552003040400475523040400475520304040047552

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075604484OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-26
08800075604460OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604477OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604491OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
10889950110512Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950110529Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950121204Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-06-27
10889950043360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950043377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080662Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080679Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
D943G18010GargPower Dental U.S.A. Inc.EJZ2023-02-28
D943G18120GargPower Dental U.S.A. Inc.EJZ2023-02-28
10889950139353Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139360Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139414Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139421Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139438Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139513Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950044251HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2022-01-20
10889950133153Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2021-10-08
D9431816D0Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812M00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431816D00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812L00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D943N1812L00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1812M00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1816D00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D94318020Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20
D94318130Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20