Skip to content

Relief ACP DIS445/01

by Discus Dental, Inc.

Relief ACP DIS445/01 is a Class II device made by Discus Dental, Inc., cleared under FDA 510(k) K062176 on 10 Jan 2007 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00075020043900), 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

None ongoing

1 closed

Documents

510(k) K062176

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 Number00075020043900 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062176 Date10 Jan 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062176 decided 10 Jan 2007 Active
  • FDA GUDID UDI-DI 00075020043900 listed 7 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0425-2015 FDA Class II initiated 24 Oct 2014

    Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.

Timeline

3 dated events

  1. Cleared FDA 510(k) K062176
  2. Recall initiated FDA recalls Z-0425-2015
  3. Listed FDA GUDID 00075020043900

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Relief ACP
Generic name
Dental coating, tooth-desensitizing, professional
Model / reference
DIS445/01
Primary DI / UDI-DI
00075020043900
510(k) Number
FDA product code
LBH
GMDN term
Dental coating, tooth-desensitizing, professional
Device class
Class II
Regulation number
872.3260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental coating, tooth-desensitizing, professional

Cleared under the same submission (K062176)

and 3 more cleared under K062176

Similar devices

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

Other devices from Discus Dental, Inc.

See all devices from Discus Dental, Inc. →

Properties

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