510(k) · Cleared
ClearedLime-Lite II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Mar 5, 2012 as substantially equivalent to K953079 (Pulpdent Corp., 1995) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Mar 5, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K860633 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK860633 Fluoroseal, Dentin Sealer and Cavity LinerScientific Pharmaceuticals, Inc. · 1986
- This deviceK113711 Lime-Lite IIPulpdent Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860633 | Fluoroseal, Dentin Sealer and Cavity Liner | Scientific Pharmaceuticals, Inc. | 1986 | — |
| 0 (this device) | K113711 | Lime-Lite II | Pulpdent Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K953079 | LimelightSummary page 1…Glass filler Pulpdent Limelight Calcium and fluoride releasing, Line cavity preparations before Acrylate resins K953079 light cured, radiopaque dental restoration. Calcium hydroxide… | 1995 |
| * | K860633 | Fluoroseal, Dentin Sealer and Cavity LinerSummary page 1…leasing, Line cavity preparations before Resin Base Fluoroseal light cured, radiopaque dental restoration Hydroxyapatite K860633 liner/base material inaresin Photo-chemistry… | 1986 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K953079.
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?
Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Lite II is used to line cavity preparations before restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113711: Lime-Lite II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113711
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