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PMMA disc Shaded PMMA B3, 12mm

by Dentsply International

Ref 8081712

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D001POLYCROWNBRIDGE7C Basic UDI-DI D00180817120UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD00180817120 UDI-DI Date23 Nov 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
PMMA disc
Generic Name
Temporary dental crown/bridge
Device Name
Shaded PMMA Disc
Model / Ref / Catalog
8081712, Shaded PMMA B3, 12mm
Primary DI / UDI-DI
D00180817120
Basic UDI-DI
++D001POLYCROWNBRIDGE7C
FDA Product Code
EBG
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Temporary dental crown/bridge
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3770
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Height — 12 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
8081712
GUDID
Shaded PMMA B3, 12mm
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Temporary dental crown/bridge

Other devices from Dentsply International

See all devices from Dentsply International →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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