# K122421: Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Dec 11, 2012 after 124 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- 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 K910424 (1991). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983477: Super Seal, Phoenix Dental, Inc. (1998) Summary page 1.
- K012742: Teethmate F-1, Kuraray Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- 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 DESENSITIZER is indicated for reduction of tooth hypersensitivity by the following treatments: [1] Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease and/or acid erosion [2] Treatment of dentin after mechanical tooth cleaning, scaling and/or root planing [3] Treatment of tooth surface after bleaching [4] Treatment of prepared dentin for fillings and/or prosthetic restorations

Source page: https://510kreport.com/device/K122421
Methodology: https://510kreport.com/methodology