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Henry Schein 9001284

by Henry Schein, Inc.

Ref 9001284Model TF-061

Henry Schein 9001284 is a device classified as Class IIa in the EU and Class II in the US made by Henry Schein, Inc., registered in EUDAMED on 7 Jun 2026 (Basic UDI-DI B-00304040001547) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040001547), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00304040001547 Basic UDI-DI 00304040001547UDI-DIDate7 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00304040001547 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00304040001547 registered 7 Jun 2026 Active
  • FDA GUDID UDI-DI 00304040001547 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00304040001547
  2. Registered EUDAMED B-00304040001547

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  • Withdrawn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
Hs EUDAMED
Henry Schein GUDID
Generic name
Temporary dental crown/bridge
Device name
MaxiTemp(1016)
Model / Ref / Catalog
9001284, TF-061
Primary DI / UDI-DI
00304040001547
Basic UDI-DI
B-00304040001547
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 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 II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II 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

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - OTHER.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)