# K181965: Restore Toothpaste

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Collins, Inc.
- Decided: Jun 13, 2019 after 325 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K200077: BioMin Restore Plus (2020), 1 descendant of its own
- K242913: Jasmate® Toothpaste (2024), 0 descendants of its own

## Indications for use
Restore Toothpaste is a fluoride-free toothpaste intended for cleaning the tooth surface on a daily basis. The toothpaste is formulated to provide rapid and continual desensitization through mechanical occlusion of exposed dentinal tubule.

Source page: https://510kreport.com/device/K181965
Methodology: https://510kreport.com/methodology