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Consepsis 546

by Ultradent Products, Inc. 2 variants

Consepsis 546 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K925375 on 22 Jul 1993 and listed in FDA GUDID since 11 Mar 2025 (UDI-DI 00883205032812), 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) K925375

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 Number00883205032812 UDI-DI Date11 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK925375 Date22 Jul 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K925375 decided 22 Jul 1993 Active
  • FDA GUDID UDI-DI 00883205032812 listed 11 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K925375
  2. Listed FDA GUDID 00883205032812

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Consepsis
Generic name
Dental tooth-cleaning solution
Model / Ref / Catalog
546
Primary DI / UDI-DI
00883205032812
510(k) Number
FDA product code
LBH
GMDN term
Dental tooth-cleaning solution
Device class
Class II
Regulation number
872.3260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental tooth-cleaning solution

Cleared under the same submission (K925375)

and 2 more cleared under K925375

Similar devices

Other devices filed under FDA product code LBH (VARNISH, CAVITY).

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)