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Candulor TCR 696817

by Candulor AG

Ref 696817

Candulor TCR 696817 is a device classified as Class IIa in the EU and Class II in the US made by Candulor AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 763081342APROS002VE) and listed in FDA GUDID since 1 Sep 2023 (UDI-DI 07630813480527), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number763081342APROS002VE Basic UDI-DI 07630813480527UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630813480527 UDI-DI Date1 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 763081342APROS002VE registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 07630813480527 listed 1 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630813480527
  2. Registered EUDAMED 763081342APROS002VE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
PhysioSelect TCR set of 6 U 790+ B2 EUDAMED
Candulor TCR GUDID
Generic name
Resin artificial teeth
Device name
Physioset TCR, Bonartic TCR, PhysioSelect TCR, BonSelect TCR, Preference, Bonartic II NFC plus, PhysioStar NFC plus, Condyloform II NFC plus
Model / Ref / Catalog
696817
Primary DI / UDI-DI
07630813480527
Basic UDI-DI
763081342APROS002VE
FDA product code
ELM
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Resin artificial teeth
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3590
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Resin artificial teeth

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES.

Other devices from Candulor AG

See all devices from Candulor AG →

Properties

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