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Odipal Posterior Teeth D4/M35I

by Union Dental SA

Part of a family of 2,240+ devices: see the family page

Ref M2D4M35IModel Artificial Teeth

Odipal Posterior Teeth D4/M35I (M2D4M35I) 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) K070591 on 11 May 2007 and listed in FDA GUDID since 12 Jan 2022 (UDI-DI 08435288429397), 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) K070591

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 08435288429397UDI-DIDate2 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08435288429397 UDI-DI Date12 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK070591 Date11 May 2007IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084352884UD-TEETHVS registered 2 Nov 2022 Active
  • FDA 510(k) K070591 decided 11 May 2007 Active
  • FDA GUDID UDI-DI 08435288429397 listed 12 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K070591
  2. Listed FDA GUDID 08435288429397
  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  • Withdrawn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
Odipal
Generic name
Resin artificial teeth
Model / Ref / Catalog
Artificial Teeth, M2D4M35I, POSTERIOR TEETH D4/M35I
Description
ODIPAL posterior Teeth Shade D4 , Mould M35 inf.
Primary DI / UDI-DI
08435288429397
Basic UDI-DI
084352884UD-TEETHVS
510(k) Number
FDA product code
ELM
EMDN code
Q01020601, Q01020602, Q01020603, Q01020605
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
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Artificial Teeth
M2D4M35I
GUDID
POSTERIOR TEETH D4/M35I
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

Cleared under the same submission (K070591)

and 8 more cleared under K070591

Similar devices in this category

Other devices filed under MOBILE DENTAL PROSTHESES.

Other devices from Union Dental SA

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Properties

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