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UltraTemp 6041

by Ultradent Products, Inc.

UltraTemp 6041 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K080768 on 11 Apr 2008 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205106872), 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) K080768

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 Number00883205106872 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK080768 Date11 Apr 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080768 decided 11 Apr 2008 Active
  • FDA GUDID UDI-DI 00883205106872 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080768
  2. Listed FDA GUDID 00883205106872

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UltraTemp
Generic name
Zinc polycarboxylate dental cement
Model / Ref / Catalog
6041
Primary DI / UDI-DI
00883205106872
510(k) Number
FDA product code
EMA
GMDN term
Zinc polycarboxylate dental cement
Device class
Class II
Regulation number
872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Zinc polycarboxylate dental cement

Cleared under the same submission (K080768)

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)