# K200077: BioMin Restore Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Collins, Inc.
- Decided: Nov 6, 2020 after 297 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 K181965 (2019). 1 ancestor in all.
1 later device descends 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)
- K181965: Restore Toothpaste, Dr. Collins, Inc. (2019) Summary page 4.

## Most influential descendants
- K242913: Jasmate® Toothpaste (2024), 0 descendants of its own

## Indications for use
Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

Source page: https://510kreport.com/device/K200077
Methodology: https://510kreport.com/methodology