510(k) · Cleared
ClearedApapro Desensitizer
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 Feb 16, 2022 as substantially equivalent to K040858 (Novamin Technology, Inc., 2004) after a 2-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Feb 16, 2022
- Review
- 2 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002989 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 2 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 1 generation backK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- This deviceK220419 Apapro DesensitizerSangi Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260830 APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity…Sangi Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −2 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −1 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| 0 (this device) | K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022 | — |
| +1 | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K040858 | Oralief Therapy for Sensitive TeethSummary page 4…1 CFR 872.326 Product code LBH) 2. Legally Marketed Predicate Device: Device Name: OraliefTM Therapy for Sensitive Teeth 510(k) Number: K040858 Applicant: NovaMin Technology, Inc. 3. Device Description: APAPRO Desensitizer is a fluoride-free tooth de… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | 2026 | 0 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260830 (Sangi Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040858.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.
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/K220419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220419: Apapro Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220419
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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