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File-Eze 297

by Ultradent Products, Inc.

Ref 297

File-Eze 297 is a device classified as Class IIa in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 11 May 2026 (Basic UDI-DI 0883205-TF002FileEzeRQ), cleared under FDA 510(k) K060335 on 24 Feb 2006 and listed in FDA GUDID since 10 Aug 2017 (UDI-DI 00883205103468), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060335

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF002FileEzeRQ Basic UDI-DI 00883205103468UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103468 UDI-DI Date10 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060335 Date24 Feb 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF002FileEzeRQ registered 11 May 2026 Active
  • FDA 510(k) K060335 decided 24 Feb 2006 Active
  • FDA GUDID UDI-DI 00883205103468 listed 10 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060335
  2. Listed FDA GUDID 00883205103468
  3. Registered EUDAMED 0883205-TF002FileEzeRQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
File-Eze
Generic name
Endodontic reaming aid material
Device name
EDTA Endodontic File Lubricant
Model / Ref / Catalog
297
Primary DI / UDI-DI
00883205103468
Basic UDI-DI
0883205-TF002FileEzeRQ
510(k) Number
FDA product code
KJI
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Endodontic reaming aid material
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
862.3520
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Endodontic reaming aid material

Cleared under the same submission (K060335)

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)