510(k) · Cleared
ClearedTeethmate F-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Sep 14, 2001 as substantially equivalent to K965091 (Kuraray Company, Ltd., 1997) after a 31-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 14, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910424 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK910424 Teethmate-FKuraray Co. · 1991
- 1 generation backK965091 Teethmate F-1Kuraray Company, Ltd. · 1997
- This deviceK012742 Teethmate F-1Kuraray Medical, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK122421 Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate…Kuraray Noritake Dental, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK131068 Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate…Kuraray Noritake Dental, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK191103 Parkell Desensitizer GelParkell, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K122421Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2012 · cites it directly2descendants
- K131068Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2013 · 2 generations on1descendant
- K191103Parkell Desensitizer GelParkell, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910424 | Teethmate-F | Kuraray Co. | 1991 | — |
| −1 | K965091 | Teethmate F-1 | Kuraray Company, Ltd. | 1997 | — |
| 0 (this device) | K012742 | Teethmate F-1 | Kuraray Medical, Inc. | 2001 | — |
| +1 | K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer… | Kuraray Noritake Dental, Inc. | 2012 | — |
| +2 | K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +3 | K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K965091 | Teethmate F-1Summary page 1…submission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. TEETHMATE F-1 by Kuraray Co., Ltd. (K965091) 4. Description for the premarket notification This product is classified into the pit and fissure sealant and conditioner, CFR… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid | 2012 | 2 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122421 (Kuraray Noritake Dental, Inc., 2012) has gone furthest, with 2 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?
TEETHMATE F-1 is indicated for the following application:
1) Pit and fissure sealant
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/K012742 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012742: Teethmate F-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012742
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026