510(k) · Cleared
ClearedJasmate® Toothpaste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jasberry Healthcare Private Limited · LBH Varnish, Cavity
Cleared on Nov 22, 2024 as substantially equivalent to K200077 (Dr. Collins, Inc., 2020) after a 59-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Nov 22, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K181965 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LBH? 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 LBH device
- #1 K262243 Profisil Freescore 12.8 · 4 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 |
|---|---|---|---|
| * | K200077 | BioMin Restore PlusSummary page 5…redicate Device S.No. Subject Device Predicate Device 1 Jasmate® BioMin® Restore Plus (K200077) Description of the Device Device Description: Page 1 of 5 Jasma… | 2020 |
| * | — | BioMinF® Toothpaste Named without a submission number |
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 5 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LBH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBH
223in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBH
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBH
7in 2025
MAUDE reports naming product code LBH, 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 | 8 | 69 | 0 | 4 |
| 2008 | 6 | 79 | 0 | 3 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 7 | 107 | 0 | 7 |
| 2011 | 3 | 72 | 0 | 8 |
| 2012 | 4 | 83 | 0 | 7 |
| 2013 | 6 | 160 | 0 | 27 |
| 2014 | 6 | 204 | 3 | 40 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 2 | 13 |
| 2019 | 2 | — | 1 | 9 |
| 2020 | 5 | 256 | 0 | 10 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 3 | 167 | 0 | 8 |
| 2024 | 3 | 237 | 0 | 6 |
| 2025 | 4 | 223 | 0 | 7 |
| 2026 | 5 | 64 | 0 | — |
What is it indicated for?
Jasmate® Toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
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/K242913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242913: Jasmate® Toothpaste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242913
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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