510(k) · Cleared
ClearedBisblock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Jan 16, 2004 as substantially equivalent to K983477 (Phoenix Dental, Inc., 1998) after a 70-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Jan 16, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983477 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983477 Super SealPhoenix Dental, Inc. · 1998
- This deviceK033521 BisblockBisco, Inc. · 2004
- 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
- Descendant · cites it directly · 0 of its ownK123653 Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)Bisco, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K120176Senzzzzz AwayCentrix, Inc. · 2012 · cites it directly2descendants
- K122708Remesense for Sensitive TeethSylphar N.V. · 2013 · 2 generations on1descendant
- K132426Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014 · 3 generations on0descendants
- K123653Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)Bisco, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983477 | Super Seal | Phoenix Dental, Inc. | 1998 | — |
| 0 (this device) | K033521 | Bisblock | Bisco, Inc. | 2004 | — |
| +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 | — |
| +1 | K123653 | Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized) | Bisco, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K983477 | Super SealSummary page 1…s are exposed. Its physical properties are similar to the predicate device and uses are identical. Predicate Device: Super Seal from Phoenix Dental, Inc., cleared under K983477 dated 12/22/1998 Significant Performance Characteristics: _________________ _____… | 1998 |
What descends from it? (4)
2 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?
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?
BisBlock forms oxalate crystals which occlude the dentin tubules resulting in a reduction
of sensitivity of teeth by applying:
1. Prior to temporization (placement of provisional restorations).
2. Prior to permanent cementation of indirect restorations.
3. Prior to placement of direct restorations.
4. When root surfaces are exposed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033521: Bisblock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033521
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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