510(k) · Cleared
ClearedD/Sense 1-Step
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centrix, Inc. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Jul 2, 2002 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK021146 D/Sense 1-StepCentrix, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- Descendant · 3 generations on · 0 of its ownK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021146 | D/Sense 1-Step | Centrix, Inc. | 2002 | — |
| +1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +2 | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| +3 | K132426 | Sylphar Remesense Sensitivity Relief Strips | Sylphar N.V. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K120176 | Senzzzzz Away | 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?
- Of its descendants, K120176 (Centrix, Inc., 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K021146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021146: D/Sense 1-Step.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021146
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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