# K062176: Relief Acp Oral Care Gel

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, Inc.
- Decided: Jan 10, 2007 after 163 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K241568: CrystLCare™ PRO Biorestorative, Fluoride-Plus (2025), 0 descendants of its own

## Recalls of this device
- Oct 24, 2014 · Class II · Z-0425-2015: 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 com

## Indications for use
Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth.

Source page: https://510kreport.com/device/K062176
Methodology: https://510kreport.com/methodology