510(k) · Cleared
ClearedFluoride Varnish (Type A,Type C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nagy Oral Technology Qinhuangdao Co., Ltd. · LBH Varnish, Cavity
Cleared on Jun 11, 2026 as substantially equivalent to K132109 (Ultradent Products Inc. / Oratech, LLC, 2013) after a 262-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Jun 11, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051750 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK051750 Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc. · 2005
- 2 generations backK080249 Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc. · 2008
- 1 generation backK132109 EnamelastUltradent Products Inc. / Oratech, LLC · 2013 · Recalled
- This deviceK253052 Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051750 | Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502 | Ultradent Products, Inc. | 2005 | — |
| −2 | K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | 2008 | — |
| −1 | K132109 | Enamelast | Ultradent Products Inc. / Oratech, LLC | 2013 | 2 |
| 0 (this device) | K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao 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 |
|---|---|---|---|
| * | K132109 | EnamelastSummary page 5…: 21 CFR 872.3260 Classification: Class II Panel: Dental 3.0 Identification of Predicate Device and Reference Device Predicate# 510(k) Number: K132109 Trade/Product Name: ENAMELAST Manufacturer: ULTRADENT PRODUCTS INC. / ORATECH LLC… | 2013 |
| † | K222891 | Dental Desensitizer | 2023 |
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 21 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K132109.
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?
The Fluoride Varnish is indicated to relieve dental hypersensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253052: Fluoride Varnish (Type A,Type C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253052
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026