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DuraCetal

by The Myerson Company Limited 139 variants

Ref DC-B10-12.5kg

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08423261ThermoplasticDR5S Basic UDI-DI 00842326103436UDI-DIDate8 Mar 2026RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00842326103436 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Dental appliance fabrication material, thermoplastic
Device Name
Thermoplastic denture base resin
Model / Reference
DC-B10-12.5kg
Primary DI / UDI-DI
00842326103436
Basic UDI-DI
08423261ThermoplasticDR5S
FDA Product Code
EBI, EHP
EMDN Code
Q0102050102 Dental rebasing resins
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3760, 872.3285
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Weight — 12.5 Kilogram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
TT-MF-000045141
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from The Myerson Company Limited

See all devices from The Myerson Company Limited →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No