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Henry Schein 1006646

by Henry Schein, Inc.

Ref 1006646Model TF-150

Henry Schein 1006646 is a manual endodontic file/rasp (EU MDD Class IIa; FDA Class I; FDA product code EKS, File, Pulp Canal, Endodontic) made by Henry Schein, Inc., registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI B-H65810066461) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI H65810066461), 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-H65810066461 Basic UDI-DI H65810066461UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberH65810066461 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-H65810066461 registered 8 Jun 2026 Active
  • FDA GUDID UDI-DI H65810066461 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID H65810066461
  2. Registered EUDAMED B-H65810066461

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  • Withdrawn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
Manual endodontic file/rasp, reusable
Device name
Paste Filler
Model / Ref / Catalog
1006646, TF-150
Primary DI / UDI-DI
H65810066461
Basic UDI-DI
B-H65810066461
FDA product code
EKS
EMDN code
Q01010299 Root canal filling devices - other
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
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 · 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: Manual endodontic file/rasp, reusable

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

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)