510(k) · Cleared
ClearedTeethmate-F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Co. · EMA Cement, Dental
Cleared on Apr 3, 1991 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 3, 1991
- Review
- 63 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK910424 Teethmate-FKuraray Co. · 1991
- Descendant · cites it directly · 4 of its ownK965091 Teethmate F-1Kuraray Company, Ltd. · 1997
- Descendant · 2 generations on · 3 of its ownK012742 Teethmate F-1Kuraray Medical, Inc. · 2001
- Descendant · 3 generations on · 2 of its ownK122421 Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate…Kuraray Noritake Dental, Inc. · 2012
- Descendant · 4 generations on · 1 of its ownK131068 Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate…Kuraray Noritake Dental, Inc. · 2013
- Descendant · 5 generations on · 0 of its ownK191103 Parkell Desensitizer GelParkell, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K965091Teethmate F-1Kuraray Company, Ltd. · 1997 · cites it directly4descendants
- K012742Teethmate F-1Kuraray Medical, Inc. · 2001 · 2 generations on3descendants
- K122421Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2012 · 3 generations on2descendants
- K131068Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2013 · 4 generations on1descendant
- K191103Parkell Desensitizer GelParkell, Inc. · 2019 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910424 | Teethmate-F | Kuraray Co. | 1991 | — |
| +1 | K965091 | Teethmate F-1 | Kuraray Company, Ltd. | 1997 | — |
| +2 | K012742 | Teethmate F-1 | Kuraray Medical, Inc. | 2001 | — |
| +3 | K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer… | Kuraray Noritake Dental, Inc. | 2012 | — |
| +4 | K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +5 | K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K965091 | Teethmate F-1 | 1997 | 4 |
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?
- Of its descendants, K965091 (Kuraray Company, Ltd., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
https://510kreport.com/device/K910424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910424: Teethmate-F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910424
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026