510(k) · Cleared
ClearedTeethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Noritake Dental, Inc. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Dec 11, 2012 as substantially equivalent to K983477 (Phoenix Dental, Inc., 1998) and 1 other predicate after a 124-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 124 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K910424 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK910424 Teethmate-FKuraray Co. · 1991
- 2 generations backK965091 Teethmate F-1Kuraray Company, Ltd. · 1997
- 1 generation backK012742 Teethmate F-1Kuraray Medical, Inc. · 2001
- This deviceK122421 Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate…Kuraray Noritake Dental, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK131068 Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate…Kuraray Noritake Dental, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK191103 Parkell Desensitizer GelParkell, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910424 | Teethmate-F | Kuraray Co. | 1991 | — |
| −2 | K965091 | Teethmate F-1 | Kuraray Company, Ltd. | 1997 | — |
| −1 | K012742 | Teethmate F-1 | Kuraray Medical, Inc. | 2001 | — |
| 0 (this device) | K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer… | Kuraray Noritake Dental, Inc. | 2012 | — |
| +1 | K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +2 | K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 EJK? 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 EJK device
- #1 K261728 One-Fil LCscore 12.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983477 | Super SealSummary page 1…code: EJK) 3) Common name Tooth Desensitizer 3-3. Predicate Device 1) SUPER SEAL 5 10(k) Number: K983477 Classification: Calcium hydroxide cavity liner… | 1998 |
| * | K012742 | Teethmate F-1Summary page 1…872.3250 Applicant: Phoenix Dental Inc. 2) TEETHMATE F-I 5 10(k) Number: K0 12742 Classification: Pit and Fissure Sealant and Conditioner… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid | 2013 | 1 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131068 (Kuraray Noritake Dental, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K983477.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EJK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · EJK
260in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EJK
No recall names EJK since 2007.
Adverse event reports per year · EJK
1in 2022
MAUDE reports naming product code EJK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 93 | 0 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 260 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122421: Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122421
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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