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Acrifix 1351350

by DeltaMed GmbH

Part of a family of 8 devices: see the family page

Ref 1351350Model Denture Resins and Accessories - Bonding Resin for Denture Resins

Acrifix 1351350 is a dental prosthesis priming agent (EU MDR Class IIa; FDA Class II) made by DeltaMed GmbH, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI ++EDELTD05BUDI020009JA), cleared under FDA 510(k) K212541 on 10 Jan 2022 and listed in FDA GUDID since 12 May 2023 (UDI-DI +EDEL13513500), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212541

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EDELTD05BUDI020009JA Basic UDI-DI +EDEL13513500UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EDEL13513500 UDI-DI Date12 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212541 Date10 Jan 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EDELTD05BUDI020009JA registered 4 Aug 2026 Active
  • FDA 510(k) K212541 decided 10 Jan 2022 Active
  • FDA GUDID UDI-DI +EDEL13513500 listed 12 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212541
  2. Listed FDA GUDID +EDEL13513500
  3. Registered EUDAMED ++EDELTD05BUDI020009JA

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  • Withdrawn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 Bonder EUDAMED
Acrifix GUDID
Generic name
Dental prosthesis priming agent
Model / Ref / Catalog
1351350, Denture Resins and Accessories - Bonding Resin for Denture Resins
Primary DI / UDI-DI
+EDEL13513500 EUDAMED
EDEL13513500 GUDID
Basic UDI-DI
++EDELTD05BUDI020009JA
510(k) Number
FDA product code
EBI, KLE
EMDN code
Q01020601, Q01020602, Q01020605
GMDN term
Dental prosthesis priming agent
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760, 872.3200
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
+EDEL13513500
GUDID
EDEL13513500
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EDEL13513500; FDA GUDID lists EDEL13513500), so their flags are not compared. 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 prosthesis priming agent

Cleared under the same submission (K212541)

and 4 more cleared under K212541

Similar devices in this category

Other devices filed under MOBILE DENTAL PROSTHESES.

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)