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ANAXDENT PMMA U Monolayer BLANK BL3 98, 5/16mm

by Union Dental SA

Ref 18970016Model Polymer blank for crowns and bridges

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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/MDD EUDAMED NumberB-08435288492537 Basic UDI-DI 08435288492537UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435288492537 UDI-DI Date15 Dec 2025ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ANAXDENT PMMA The Preview EUDAMED
Anaxdent Pmma GUDID
Generic Name
Temporary dental crown/bridge
Model / Ref / Catalog
Polymer blank for crowns and bridges, 18970016, U Monolayer BLANK BL3 98, 5/16mm
Primary DI / UDI-DI
08435288492537
Basic UDI-DI
B-08435288492537
510(k) Number
FDA Product Code
EBG
EMDN Code
P01020101 Dental implants
GMDN Term
Temporary dental crown/bridge
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3770
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Polymer blank for crowns and bridges
18970016
GUDID
U Monolayer BLANK BL3 98,5/16mm
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Expiration Date: No
  • Manufacturing Date: No