510(k) · Cleared
ClearedTeethmate F-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Company, Ltd. · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Mar 27, 1997 as substantially equivalent to K910424 (Kuraray Co., 1991) after a 98-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Mar 27, 1997
- Review
- 98 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910424 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910424 Teethmate-FKuraray Co. · 1991
- This deviceK965091 Teethmate F-1Kuraray Company, Ltd. · 1997
- Descendant · cites it directly · 3 of its ownK012742 Teethmate F-1Kuraray Medical, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK122421 Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate…Kuraray Noritake Dental, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK131068 Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate…Kuraray Noritake Dental, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK191103 Parkell Desensitizer GelParkell, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K012742Teethmate F-1Kuraray Medical, Inc. · 2001 · cites it directly3descendants
- K122421Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2012 · 2 generations on2descendants
- K131068Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2013 · 3 generations on1descendant
- K191103Parkell Desensitizer GelParkell, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910424 | Teethmate-F | Kuraray Co. | 1991 | — |
| 0 (this device) | K965091 | Teethmate F-1 | Kuraray Company, Ltd. | 1997 | — |
| +1 | K012742 | Teethmate F-1 | Kuraray Medical, Inc. | 2001 | — |
| +2 | K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer… | Kuraray Noritake Dental, Inc. | 2012 | — |
| +3 | K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +4 | K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBC device
- #1 K243254 Parkell Pit and Fissure Sealantscore 12.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910424 | Teethmate-FSummary page 2…teristics This device is developed as a simplified material on handling of Kuraray's TEETHMATE-F which was permitted to be marketed by registration of its 510(k) number K910424. The sealant resin of this device is a single-liquid type which is improved from the two-liquids type of TEETHMATE-F. The chemic… | 1991 |
| * | — | Delton Plus Named without a submission number | |
| * | — | White Sealant LC Named without a submission number | |
| * | — | Fluro Shield Named without a submission number | |
| * | — | Fluoro Bond Named without a submission number | |
| * | — | Helioseal Named without a submission number | |
| † | K943170 | Clearfil Liner Bond 2 | 1994 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012742 | Teethmate F-1 | 2001 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K012742 (Kuraray Medical, Inc., 2001) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EBC devicesEBC Sealant, Pit And Fissure, And Conditioner: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBC
80in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBC
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBC
6in 2025
MAUDE reports naming product code EBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 5 | 115 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 5 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 11 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 2 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965091: Teethmate F-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965091
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026