# K012742: Teethmate F-1

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 14, 2001 after 31 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910424 (1991). 2 ancestors in all.
3 later devices descend 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)
- K965091: Teethmate F-1, Kuraray Company, Ltd. (1997) Summary page 1.

## Most influential descendants
- K122421: Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid (2012), 2 descendants of its own
- K131068: Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid (2013), 1 descendant of its own
- K191103: Parkell Desensitizer Gel (2019), 0 descendants of its own

## Indications for use
TEETHMATE F-1 is indicated for the following application: 1) Pit and fissure sealant

Source page: https://510kreport.com/device/K012742
Methodology: https://510kreport.com/methodology