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Acrifix 1351340

by DeltaMed GmbH

Ref 1351340Model Denture Resins and Accessories - Light Curing Denture Resins - Gels

Acrifix 1351340 is a device classified as Class IIa in the EU and Class II in the US made by DeltaMed GmbH, registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI ++EDELTD05BUDI010008HV), cleared under FDA 510(k) K230341 on 6 Apr 2023 and listed in FDA GUDID since 12 May 2023 (UDI-DI +EDEL13513400), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230341

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EDELTD05BUDI010008HV Basic UDI-DI +EDEL13513400UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EDEL13513400 UDI-DI Date12 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230341 Date6 Apr 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EDELTD05BUDI010008HV registered 12 Aug 2026 Active
  • FDA 510(k) K230341 decided 6 Apr 2023 Active
  • FDA GUDID UDI-DI +EDEL13513400 listed 12 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230341
  2. Listed FDA GUDID +EDEL13513400
  3. Registered EUDAMED ++EDELTD05BUDI010008HV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ACRIFIX rosa-opak EUDAMED
Acrifix GUDID
Generic name
Dental prosthesis restorative material, unfilled resin
Model / Ref / Catalog
1351340, Denture Resins and Accessories - Light Curing Denture Resins - Gels
Primary DI / UDI-DI
+EDEL13513400 EUDAMED
EDEL13513400 GUDID
Basic UDI-DI
++EDELTD05BUDI010008HV
510(k) Number
FDA product code
EBI
EMDN code
Q010280 Prosthetic dentistry devices - accessories
GMDN term
Dental prosthesis restorative material, unfilled resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+EDEL13513400
GUDID
EDEL13513400
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Dental prosthesis restorative material, unfilled resin

Cleared under the same submission (K230341)

Other devices from DeltaMed GmbH

See all devices from DeltaMed GmbH →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)