FDA.reportPublic FDA data

Henry Schein

Primary DI
H6581001131
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1001131
Catalog number
1001131
Device description
Zinc Cement Powder Yellow
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H6581001131PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Zinc phosphate dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. It typically includes some additional fillers/components. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight29Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040199602Henry Schein570599457059942026-10-01
00304040199619Henry Schein570599557059952026-10-01
00304040199626Henry Schein570599657059962026-10-01
00304040199633Henry Schein570599757059972026-10-01
00304040199640Henry Schein570599857059982026-10-01
00304040199657Henry Schein570599957059992026-10-01
00304040199664Henry Schein570600057060002026-10-01
00304040199671Henry Schein570600157060012026-10-01
00304040199312Henry Schein570597057059702026-09-30
00304040199091Henry Schein570594357059432026-09-29
00304040199107Henry Schein570594657059462026-09-29
00304040199114Henry Schein570594457059442026-09-29
00304040199121Henry Schein570594757059472026-09-29
00304040199138Henry Schein570594557059452026-09-29
00304040199145Henry Schein570594857059482026-09-29
00304040199152Henry Schein570594957059492026-09-29
00304040199169Henry Schein570595157059512026-09-29
00304040199176Henry Schein570595057059502026-09-29
00304040199183Henry Schein570595257059522026-09-29
00304040199190Henry Schein570595357059532026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118536NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
08809911118543NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14