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File-Eze

by Ultradent Products, Inc. 2 variants

510(k) K060335

File-Eze is a device classified as Unclassified made by Ultradent Products, Inc., cleared under FDA 510(k) K060335 on 24 Feb 2006 and registered in EUDAMED, active as of 22 Oct 2026.

Active European Union and United States

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060335↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK060335 Date24 Feb 2006ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060335 decided 24 Feb 2006 Active
  • EUDAMED Active

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  • Withdrawn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 · 510(k)

510(k) Number
FDA product code
KJJ
Device class
U
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent

Devices cleared under K060335

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K060335
UDI-DISize and differences
File-Eze 1075
ULTRADENT PRODUCTS, INC.
1075 / 107500883205103956
Single use: no
On the market
File-Eze 297
ULTRADENT PRODUCTS, INC.
297 / 29700883205103468
Single use: no
On the market
File-Eze 682
ULTRADENT PRODUCTS, INC.
682 / 68200883205105875
Single use: no
On the market
File-Eze S127-CE
ULTRADENT PRODUCTS, INC.
S127-CE / S127-CE00883205019356
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code KJJ (Cleanser, Root Canal).

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →