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Henry Schein 9003663

by Henry Schein, Inc.

Ref 9003663Model TF-029

Henry Schein 9003663 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 12 Jun 2026 (Basic UDI-DI B-00304040096826) and listed in FDA GUDID since 12 Jan 2017 (UDI-DI 00304040096826), 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-00304040096826 Basic UDI-DI 00304040096826UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00304040096826 UDI-DI Date12 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00304040096826 registered 12 Jun 2026 Active
  • FDA GUDID UDI-DI 00304040096826 listed 12 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00304040096826
  2. Registered EUDAMED B-00304040096826

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  • Withdrawn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
Calcium hydroxide dental suspension
Device name
Temporary Root Canal Filling
Model / Ref / Catalog
9003663, TF-029
Primary DI / UDI-DI
00304040096826 EUDAMED
00304040037089 GUDID
Basic UDI-DI
B-00304040096826
FDA product code
KIF
EMDN code
Q01010299 Root canal filling devices - other
GMDN term
Calcium hydroxide dental suspension
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3820
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00304040096826
GUDID
00304040037089
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00304040096826; FDA GUDID lists 00304040037089), so their flags are not compared. 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: Calcium hydroxide dental suspension

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DEVICES - OTHER.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)