FDA.reportPublic FDA data

Allcem Core

Primary DI
07899633815210
Brand
Allcem Core
Company
Dentscare Ltda
Model
Opaque Pearl 6g
Catalog number
4000019283
Device description
Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up.
Published
2019-12-02
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
EBFMaterial, Tooth Shade, Resin
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183465000Allcem, Allcem CoreDentscare Ltda2019-11-02EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899633815210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899633815210078996338152107899633815210

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898067533
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899633835249 PrimmaArtA1 7G40000566302025-04-08
07899633835256 PrimmaArtA2 7G 40000566312025-04-08
07899633835263 PrimmaArtA3 7G 40000566322025-04-08
07899633835270 PrimmaArtB1 7G 40000566332025-04-08
07899633835287 PrimmaArtBLEACH 7G 40000566342025-04-08
07899633835294 PrimmaArtA1 75G 40000566352025-04-08
07899633835300 PrimmaArtA2 75G 40000566362025-04-08
07899633835317 PrimmaArtA3 75G 4000056637 2025-04-08
07899633835324 PrimmaArtB1 75G 4000056638 2025-04-08
07899633835331 PrimmaArtBLEACH 75G 40000566392025-04-08
07899633835461 PrimmaArtCART 75G 20UN 40000566482025-04-08
07899633835478 PrimmaArtCART 75G 5UN 40000566492025-04-08
07899633835485 PrimmaArtREFIL 7G 20UN 40000566502025-04-08
07899633835492 PrimmaArtREFIL 7G 5UN 40000566512025-04-08
07899633835232Vittra APS Unique Flow2g40000566272024-11-26
07899633830886Suppra Universal Bond5mL40000559152023-06-01
07899633830893All Smiles Safebond5mL40000559112023-06-01
07899633828364Suppra Bond A Plus6mL40000554802021-10-01
07899633816552Allcem Veneer APSMini Kit40000192972020-09-14
07899633815913Ambar APS6mL40000193582020-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591676DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591720DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591911DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
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
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07
07630243601301ParaCoreDent4You AGEBF2026-07-07
07630243634743ParaCoreDent4You AGEBF2026-07-07
07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
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
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02