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EndoREZ 5901

by Ultradent Products, Inc.

EndoREZ 5901 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K042756 on 26 Oct 2004 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205107824), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K042756

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883205107824 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK042756 Date26 Oct 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042756 decided 26 Oct 2004 Active
  • FDA GUDID UDI-DI 00883205107824 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042756
  2. Listed FDA GUDID 00883205107824

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EndoREZ
Generic name
Dental composite resin
Model / Ref / Catalog
5901
Primary DI / UDI-DI
00883205107824
FDA product code
KIF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endodontic filling/sealing material

Cleared under the same submission (K042756)

Similar devices in this category

Other devices filed under Endodontic filling/sealing material.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)