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10TEMP DISC B3 10 LAYERS 98, 5/25mm

by Union Dental SA

Ref D8A185Model Artificial Teeth

10TEMP DISC B3 10 LAYERS 98, 5/25mm (RGW10-B3-25) is a device classified as Class IIa in the EU and Class II in the US made by Union Dental SA, registered in EUDAMED on 2 Nov 2022 (Basic UDI-DI 084352884UD-TEETHVS), cleared under FDA 510(k) K150432 on 14 Aug 2015 and listed in FDA GUDID since 10 Dec 2019 (UDI-DI 08435288480473), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150432

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084352884UD-TEETHVS Basic UDI-DI 08435288480473UDI-DIDate2 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08435288480473 UDI-DI Date10 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150432 Date14 Aug 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084352884UD-TEETHVS registered 2 Nov 2022 Active
  • FDA 510(k) K150432 decided 14 Aug 2015 Active
  • FDA GUDID UDI-DI 08435288480473 listed 10 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150432
  2. Listed FDA GUDID 08435288480473
  3. Registered EUDAMED 084352884UD-TEETHVS

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  • Withdrawn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
Elephandens EUDAMED
10TEMP GUDID
Generic name
Temporary dental crown/bridge
Model / Ref / Catalog
Artificial Teeth EUDAMED
D8A185 EUDAMED
DISC B3 10 LAYERS 98 GUDID
5/25mm GUDID
RGW10-B3-25 GUDID
Primary DI / UDI-DI
08435288480473
Basic UDI-DI
084352884UD-TEETHVS
510(k) Number
FDA product code
EBG
EMDN code
Q01020601, Q01020602, Q01020603, Q01020605
GMDN term
Temporary dental crown/bridge
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3770
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Artificial Teeth
D8A185
GUDID
DISC B3 10 LAYERS 98,5/25mm
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Temporary dental crown/bridge

Cleared under the same submission (K150432)

and 8 more cleared under K150432

Other devices from Union Dental SA

See all devices from Union Dental SA →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)