510(k) · Cleared
ClearedSuper Seal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Dental, Inc. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Dec 22, 1998 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Dec 22, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK983477 Super SealPhoenix Dental, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK033521 BisblockBisco, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK082594 RemesenseRemedent NV · 2009
- Descendant · cites it directly · 2 of its ownK122421 Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate…Kuraray Noritake Dental, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK131068 Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate…Kuraray Noritake Dental, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K033521BisblockBisco, Inc. · 2004 · cites it directly4descendants
- K082594RemesenseRemedent NV · 2009 · cites it directly3descendants
- K122421Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2012 · cites it directly2descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · cites it directly2descendants
- K131068Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983477 | Super Seal | Phoenix Dental, Inc. | 1998 | — |
| +1 | K033521 | Bisblock | Bisco, Inc. | 2004 | — |
| +1 | K082594 | Remesense | Remedent NV | 2009 | — |
| +1 | K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer… | Kuraray Noritake Dental, Inc. | 2012 | — |
| +1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +2 | K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate… | Kuraray Noritake Dental, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K033521 (Bisco, Inc., 2004) has gone furthest, with 4 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 | — |
What is it indicated for?
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983477: Super Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983477
Report an extraction error
Are you the manufacturer?
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