# K241489: ReminGel

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med, Inc.
- Decided: Jan 8, 2025 after 229 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: 3 generations back to K030922 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120109: Super Seal Tooth Desensitizer, Phoenix Dental, Inc. (2012) Summary page 5.

## Most influential descendants
- K262243: Profisil Free (2026), 0 descendants of its own

## Indications for use
To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.

Source page: https://510kreport.com/device/K241489
Methodology: https://510kreport.com/methodology