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IDODENTINE DISC CLEAR 95/20mm

by Union Dental SA

Ref 4250Z/CModel Polymer blank for splints

IDODENTINE DISC CLEAR 95/20mm (4250Z/C) 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 17 Apr 2026 (Basic UDI-DI 084352884UD-PBSPLINTSVH), cleared under FDA 510(k) K150432 on 14 Aug 2015 and listed in FDA GUDID since 16 Dec 2016 (UDI-DI 08435288442846), 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-PBSPLINTSVH Basic UDI-DI 08435288442846UDI-DIDate17 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435288442846 UDI-DI Date16 Dec 2016ListedStatusListed 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-PBSPLINTSVH registered 17 Apr 2026 Active
  • FDA 510(k) K150432 decided 14 Aug 2015 Active
  • FDA GUDID UDI-DI 08435288442846 listed 16 Dec 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150432
  2. Listed FDA GUDID 08435288442846
  3. Registered EUDAMED 084352884UD-PBSPLINTSVH

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  • Withdrawn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
Idodentine Splints EUDAMED
Idodentine GUDID
Generic name
Temporary dental crown/bridge
Model / Ref / Catalog
Polymer blank for splints, 4250Z/C, DISC CLEAR 95/20mm
Primary DI / UDI-DI
08435288442846
Basic UDI-DI
084352884UD-PBSPLINTSVH
510(k) Number
FDA product code
EBI, MQC, EBG
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Temporary dental crown/bridge
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760, 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
Polymer blank for splints
4250Z/C
GUDID
DISC CLEAR 95/20mm
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)