510(k) · Cleared
ClearedParkell Desensitizer Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parkell, Inc. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Nov 22, 2019 as substantially equivalent to K131068 (Kuraray Noritake Dental, Inc., 2013) after a 211-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Nov 22, 2019
- Review
- 211 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910424 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK910424 Teethmate-FKuraray Co. · 1991
- 4 generations backK965091 Teethmate F-1Kuraray Company, Ltd. · 1997
- 3 generations backK012742 Teethmate F-1Kuraray Medical, Inc. · 2001
- 2 generations backK122421 Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate…Kuraray Noritake Dental, Inc. · 2012
- 1 generation backK131068 Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate…Kuraray Noritake Dental, Inc. · 2013
- This deviceK191103 Parkell Desensitizer GelParkell, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910424 | Teethmate-F | Kuraray Co. | 1991 | — |
| −4 | K965091 | Teethmate F-1 | Kuraray Company, Ltd. | 1997 | — |
| −3 | K012742 | Teethmate F-1 | Kuraray Medical, Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 |
|---|---|---|---|
| * | K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidSummary page 4…liner Regulation Number: 21 CFR 872.3250 Product Code: EJK Device Classification II 3. Primary Predicate Teethmate Desensitizer, K131068, Kuraray Noritake Dental Inc. 4. Device Description Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment s… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:
treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion;
treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
treatment of tooth hypersensitivity associated with bleaching; and
treatment of prepared dentin for fillings and/or prosthetic restorations.
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/K191103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191103: Parkell Desensitizer Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191103
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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