Skip to content

Henry Schein 9004540

by Henry Schein, Inc.

Ref 9004540Model TF-010

Henry Schein 9004540 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 28 May 2026 (Basic UDI-DI B-10304040075965) and listed in FDA GUDID since 12 Nov 2019 (UDI-DI 10304040075965), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10304040075965 Basic UDI-DI 10304040075965UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10304040075965 UDI-DI Date12 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10304040075965 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 10304040075965 listed 12 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10304040075965
  2. Registered EUDAMED B-10304040075965

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  • Withdrawn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
Henry Schein Maxima EUDAMED
Henry Schein GUDID
Generic name
Carbide dental bur, reusable
Device name
Steel & TC Burs
Model / Ref / Catalog
9004540, TF-010
Primary DI / UDI-DI
10304040075965 EUDAMED
00304040075968 GUDID
Basic UDI-DI
B-10304040075965
FDA product code
EJL
EMDN code
Z12110102 Dental drills
GMDN term
Carbide dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10304040075965
GUDID
00304040075968
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10304040075965; FDA GUDID lists 00304040075968), so their flags are not compared. 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: Carbide dental bur, reusable

Similar devices in this category

Other devices filed under DENTAL DRILLS.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)