Skip to content

ODUS - Pella Transparent Crown Forms - N°11 - Box of 6 pairs

by Produits Dentaires SA

Ref 33491d

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764015916PELLADY Basic UDI-DI 07640159160540UDI-DIDate11 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07640159160540 UDI-DI Date28 Jun 2022ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
ODUS - Pella Transparent Crown Forms - N°11 - Box of 6 pairs EUDAMED
ODUS "PELLA" Transparent CROWN FORMS - Box of 12 crowns - R/L 11 GUDID
Generic Name
Preformed dental crown, temporary
Device Name
Pella Transparent Crown Forms - N°1 - Box of 6 pairs
Model / Reference
33491d
Primary DI / UDI-DI
07640159160540
Basic UDI-DI
764015916PELLADY
FDA Product Code
ELZ
EMDN Code
Q01020502 Pre-formed dental crowns
GMDN Term
Preformed dental crown, temporary
Device Class
Class I
Regulation Number
872.3330
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CH-MF-000023147
Authorised representative
PD DENTAL EU SAS FR-AR-000017144

Other devices from Produits Dentaires SA

See all devices from Produits Dentaires SA →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No