FDA.reportPublic FDA data

Allcem Veneer Try-in

Primary DI
07899633825776
Brand
Allcem Veneer Try-in
Company
Dentscare Ltda
Model
A2 2g
Catalog number
4000055065
Device description
Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.
Published
2020-05-31
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191389000Allcem Veneer APSDentscare Ltda2020-02-25EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899633825776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899633825776078996338257767899633825776

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. 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

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08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
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