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Eledent Posterior Teeth C2/31MI

by Union Dental SA

Ref M9C231MIModel Artificial Teeth

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08435288467740 UDI-DI Date25 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number084352884UD-TEETHVS Basic UDI-DI 08435288467740UDI-DIDate2 Nov 2022RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK070591 Date11 May 2007IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Eledent
Generic name
Resin artificial teeth
Model / Ref / Catalog
Artificial Teeth, M9C231MI, POSTERIOR TEETH C2/31MI
Primary DI / UDI-DI
08435288467740
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
M9C231MI
GUDID
POSTERIOR TEETH C2/31MI
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Resin artificial teeth

Cleared under the same submission (K070591)

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Properties

  • Single use
  • Lot / batch number

Other properties (23)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No