Skip to content

PRO Resins Crown X 019.3221

by DeltaMed GmbH

Part of a family of 48 devices: see the family page

Ref 019.3221Model Light Curing Resins for Additive Manufacturing of Anterior and Posterior Restorations

PRO Resins Crown X 019.3221 is a device classified as Class IIa in the EU and Class II in the US made by DeltaMed GmbH, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI ++EDELTD09BUDI050033P4), cleared under FDA 510(k) K211804 on 6 Dec 2021 and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 04260635981259), 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) K211804

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++EDELTD09BUDI050033P4 Basic UDI-DI 04260635981259UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260635981259 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211804 Date6 Dec 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EDELTD09BUDI050033P4 registered 13 Aug 2026 Active
  • FDA 510(k) K211804 decided 6 Dec 2021 Active
  • FDA GUDID UDI-DI 04260635981259 listed 23 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211804
  2. Listed FDA GUDID 04260635981259
  3. Registered EUDAMED ++EDELTD09BUDI050033P4

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  • Withdrawn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
PRO Resins Crown X A2 EUDAMED
PRO Resins Crown X GUDID
Generic name
Dental appliance fabrication material, combination-material
Model / Ref / Catalog
019.3221, Light Curing Resins for Additive Manufacturing of Anterior and Posterior Restorations
Primary DI / UDI-DI
04260635981259
Basic UDI-DI
++EDELTD09BUDI050033P4
510(k) Number
FDA product code
EBF
EMDN code
Q01010103, Q0102050199, Q01020601, Q01020602, Q01020605
GMDN term
Dental appliance fabrication material, combination-material
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
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
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 appliance fabrication material, combination-material

Cleared under the same submission (K211804)

and 8 more cleared under K211804

Similar devices in this category

Other devices filed under DENTISTRY RESINS - OTHER.

Other devices from DeltaMed GmbH

See all devices from DeltaMed GmbH →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)