510(k) · Cleared
ClearedAPAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sangi Co., Ltd. · LBH Varnish, Cavity
Cleared on Mar 18, 2026 as substantially equivalent to K220419 (Sangi Co., Ltd., 2022) after a 5-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Mar 18, 2026
- Review
- 5 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002989 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 3 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 2 generations backK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- 1 generation backK220419 Apapro DesensitizerSangi Co., Ltd. · 2022
- This deviceK260830 APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity…Sangi Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −3 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −2 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| −1 | K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022 | — |
| 0 (this device) | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | 2026 | — |
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 12.9 · 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? (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 |
|---|---|---|---|
| * | K220419 | Apapro DesensitizerSummary page 5…paste Classification Name: Cavity Varnish (21 CFR 872.326 Product code LBH) 2. Legally Marketed Predicate Device: Device Name: APAPRO Desensitizer 510(k) Number: (K220419) Applicant: Sangi Co., Ltd. 3. Legally Marketed Reference Device: Device Name: Oralief OTC Toothpaste for Sensitive Teeth… | 2022 |
| † | K080228 | Oralief Otc Toothpaste for Sensitive Teeth | 2008 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 4 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. 2026, 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?
APAPRO Desensitizer Homecare is a fluoride-free daily-use cleaning toothpaste that also provides relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of occluding dentin tubules through surface coating, promoting an environment conducive to remineralization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260830 · printed Nov 3, 2026
Cite this page
510(k) Report. “K260830: APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260830
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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