FDA.reportPublic FDA data

Insure

Primary DI
D7796051070
Brand
Insure
Company
COSMEDENT, INC.
Model
605107
Catalog number
605107
Published
2016-09-22
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873356000INSURE PORCELAIN VENEER BONDING SYSTEMCosmedent, Inc.1987-12-29EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7796051070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fatty acid dental cementA non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113911689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7796611010PorcelEtch6611016611012016-09-22
D7796631010PorcelEtch6631016631012016-09-22
D7796631020PorcelEtch6631026631022016-09-22
D7796631030CompositeEtch6631036631032016-09-22
D7796631040PorcelEtch6631046631042016-09-22
D7796040153Prevue Refill Kit6040156040152016-09-22
D7799060000Enamelize9060009060002016-09-22
D7799061010Enamelize9061019061012016-09-22
D7799061040Porcelize9061049061042016-09-22
D7799061050Porcelize9061059061052016-09-22
D7799061021Porcelize Kit9061022020-01-21
D7796541030Complete Dual-Cure Catalyst6541036541032016-09-22
D7796541040Complete Unfilled Resin6541046541042016-09-22
D7796061A20Renamel® Microhybrid6061A26061A22016-09-22
D7796062A21Renamel® Microhybrid6062A26062A22016-09-22
D7796062B21Renamel® Microhybrid6062B26062B22016-09-22
D7796062MI1Renamel® Microhybrid6062MI6062MI2016-09-22
D779100ROD1IPC Off-Angle Long100ROD2023-09-12
D77990110114ResinKeeper9011012020-02-17
D77970110W0Renamel® Flowable Microhybrid70110W70110W2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29