Skip to content

Henry Schein 5701288

by Henry Schein, Inc.

Ref 5701288Model TF-528 (HS)

Henry Schein 5701288 is a Class I device made by Henry Schein, Inc., registered in EUDAMED on 7 Jun 2026 (Basic UDI-DI B-10304040102920) and listed in FDA GUDID since 20 Jun 2019 (UDI-DI 10304040102920), 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-10304040102920 Basic UDI-DI 10304040102920UDI-DIDate7 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10304040102920 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10304040102920 registered 7 Jun 2026 Active
  • FDA GUDID UDI-DI 10304040102920 listed 20 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10304040102920
  2. Registered EUDAMED B-10304040102920

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  • Withdrawn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
Headstroemfile
Model / Ref / Catalog
5701288, TF-528 (HS)
Primary DI / UDI-DI
10304040102920
Basic UDI-DI
B-10304040102920
FDA product code
EKS
EMDN code
L159004 Endodontic rasps and files, reusable
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class I
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
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Sterilise before use UDI-DI 10304040102920: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Manual endodontic file/rasp, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - VARIOUS.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)