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Vit-l-escence 2245

by Ultradent Products, Inc.

Vit-l-escence 2245 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K974282 on 29 Jan 1998 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205106483), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K974282

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 Number00883205106483 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974282 Date29 Jan 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974282 decided 29 Jan 1998 Active
  • FDA GUDID UDI-DI 00883205106483 listed 22 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3066-2024 FDA Class II initiated 2 Aug 2024

    Due to a manufacturing issue, red particulates present in the expressed composite.

Timeline

3 dated events

  1. Cleared FDA 510(k) K974282
  2. Listed FDA GUDID 00883205106483
  3. Recall initiated FDA recalls Z-3066-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vit-l-escence
Generic name
Dental composite resin
Model / Ref / Catalog
2245
Primary DI / UDI-DI
00883205106483
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K974282)

and 8 more cleared under K974282

Similar devices in this category

Other devices filed under Dental composite resin.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

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