# K241568: CrystLCare™ PRO Biorestorative, Fluoride-Plus

- Pathway: 510(k) (Traditional)
- Applicant: GreenMark Biomedical, Inc.
- Decided: Jan 2, 2025 after 216 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062176 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062176: Relief Acp Oral Care Gel, Discus Dental, Inc. (2007) Summary page 5.

## Indications for use
Indicated for relief of discomfort from dentin sensitivity.

Source page: https://510kreport.com/device/K241568
Methodology: https://510kreport.com/methodology