# K965091: Teethmate F-1

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Company, Ltd.
- Decided: Mar 27, 1997 after 98 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: 1 generation back to K910424 (1991). 1 ancestor in all.
4 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)
- K910424: Teethmate-F, Kuraray Co. (1991) Summary page 2.
- (no number) Delton Plus: named in the summary without a submission number
- (no number) White Sealant LC: named in the summary without a submission number
- (no number) Fluro Shield: named in the summary without a submission number
- (no number) Fluoro Bond: named in the summary without a submission number
- (no number) Helioseal: named in the summary without a submission number

## Most influential descendants
- K012742: Teethmate F-1 (2001), 3 descendants of its own
- 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
This device is used as a sealing material for pit and fissure. This intended use is same to that of similar products which are identified in the paragraph 4.

Source page: https://510kreport.com/device/K965091
Methodology: https://510kreport.com/methodology