Skip to content

Amelogen Plus 3254

by Ultradent Products, Inc.

Amelogen Plus 3254 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K043119 on 17 Dec 2004 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205106667), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K043119

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 Number00883205106667 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK043119 Date17 Dec 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043119 decided 17 Dec 2004 Active
  • FDA GUDID UDI-DI 00883205106667 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043119
  2. Listed FDA GUDID 00883205106667

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Amelogen Plus
Generic name
Dental composite resin
Model / Ref / Catalog
3254
Primary DI / UDI-DI
00883205106667
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K043119)

and 8 more cleared under K043119

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)