FDA.reportPublic FDA data

Medental

Primary DI
P07502291840028
Brand
Medental
Company
MEDENTAL INTERNATIONAL INC
Model
PCCS25g15ml
Catalog number
0PT452
Device description
P.C.A. Cement kit 25gr. 15ml.
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
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
K980990000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980990000POLYCARBOXYLATE CEMENTMedental Intl.1998-07-31EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
P07502291840028PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Zinc polycarboxylate 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 zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082167227
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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