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Henry Schein 9006458

by Henry Schein, Inc.

Ref 9006458Model TF-012

Henry Schein 9006458 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 3 Jun 2026 (Basic UDI-DI B-10304040081713) and listed in FDA GUDID since 20 Nov 2019 (UDI-DI 10304040081713), 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-10304040081713 Basic UDI-DI 10304040081713UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10304040081713 UDI-DI Date20 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10304040081713 registered 3 Jun 2026 Active
  • FDA GUDID UDI-DI 10304040081713 listed 20 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10304040081713
  2. Registered EUDAMED B-10304040081713

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  • Withdrawn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
Root canal post kit
Device name
Screw Posts
Model / Ref / Catalog
9006458, TF-012
Primary DI / UDI-DI
10304040081713
Basic UDI-DI
B-10304040081713
FDA product code
ELR
EMDN code
Q010105 Reconstruction endodontic pins
GMDN term
Root canal post kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3810
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
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No
ImplantableEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10304040081713: EUDAMED states Yes, FDA GUDID states No.

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.

Similar devices in this category

Other devices filed under RECONSTRUCTION ENDODONTIC PINS.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)