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Zirlux 9012437

by Henry Schein, Inc.

Ref 9012437Model TF-051

Zirlux 9012437 is a device classified as Class IIa in the EU and Class I in the US made by Henry Schein, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-00304040070659) and listed in FDA GUDID since 4 Dec 2018 (UDI-DI 00304040070659), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00304040070659 Basic UDI-DI 00304040070659UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00304040070659 UDI-DI Date4 Dec 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00304040070659 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00304040070659 listed 4 Dec 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00304040070659
  2. Registered EUDAMED B-00304040070659

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  • Withdrawn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
Zirlux
Generic name
Temporary dental crown/bridge resin
Device name
Zirlux Acetal Milling Disc Duracetal
Model / Ref / Catalog
9012437, TF-051
Primary DI / UDI-DI
00304040070659
Basic UDI-DI
B-00304040070659
FDA product code
EHP
EMDN code
Q0102050102 Dental rebasing resins
GMDN term
Temporary dental crown/bridge resin
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3285
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Temporary dental crown/bridge resin

Similar devices in this category

Other devices filed under DENTAL REBASING RESINS.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (23, all answered No)