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Allcem Core Opaque Pearl 6g

by Dentscare Ltda

Ref 4000019283

Allcem Core Opaque Pearl 6g (4000019283) is a device classified as Class IIa in the EU and Class II in the US made by Dentscare Ltda, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 78996338CEM002VH) and listed in FDA GUDID since 2 Dec 2019 (UDI-DI 07899633815210), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number78996338CEM002VH Basic UDI-DI 07899633815210UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899633815210 UDI-DI Date2 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 78996338CEM002VH registered 1 Jul 2026 Active
  • FDA GUDID UDI-DI 07899633815210 listed 2 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899633815210
  2. Registered EUDAMED 78996338CEM002VH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Allcem Core Opaque Pearl EUDAMED
Allcem Core GUDID
Generic name
Dental composite resin
Model / Ref / Catalog
4000019283, Opaque Pearl 6g
Primary DI / UDI-DI
07899633815210
Basic UDI-DI
78996338CEM002VH
FDA product code
EBF, EMA
EMDN code
Q0101010201 Dental base cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690, 872.3275
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4000019283
GUDID
Opaque Pearl 6g
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

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Other devices filed under DENTAL BASE CEMENTS.

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)