510(k) · Cleared
Recalled · Class II · 2018Enamelast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products Inc. / Oratech, LLC · LBH Varnish, Cavity
Cleared on Nov 1, 2013 as substantially equivalent to K080249 (Ultradent Products, Inc., 2008) after a 116-day review. Its family tree reaches back 2 generations to 2005. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 1, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- LBH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051750 (2005). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK051750 Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc. · 2005
- 1 generation backK080249 Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc. · 2008
- This deviceK132109 EnamelastUltradent Products Inc. / Oratech, LLC · 2013
- Descendant · cites it directly · 0 of its ownK253052 Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243777 Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry)…Theodent, LLC · 2025
- Descendant · cites it directly · 0 of its ownK141422 Profluoro Fluoride VarnishPac-Dent International, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd. · 2026 · cites it directly0descendants
- K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3%…Theodent, LLC · 2025 · cites it directly0descendants
- K141422Profluoro Fluoride VarnishPac-Dent International, Inc. · 2014 · cites it directly0descendants
- K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051750 | Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502 | Ultradent Products, Inc. | 2005 | — |
| −1 | K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | 2008 | — |
| 0 (this device) | K132109 | Enamelast | Ultradent Products Inc. / Oratech, LLC | 2013 | — |
| +1 | K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | 2026 | — |
| +1 | K243777 | Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™… | Theodent, LLC | 2025 | — |
| +1 | K141422 | Profluoro Fluoride Varnish | Pac-Dent International, Inc. | 2014 | — |
| +1 | K140349 | Starbright 5% Sodium Fluoride Varnish | Nanova Biomaterials, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2025 | 1 | 0 |
| 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 12.9 · 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 |
|---|---|---|---|
| * | K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Summary page 2…characteristics Table 7-1: Substantial equivalence comparison Characteristic Comparison Product (Flor-Opal Varnish White K080249) Enamelast' Intended Use Flor-Opal Varnish White is S%sodium Enamelast" Fluoride Varnish i… | 2008 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2018 | Class II | Z-0690-2019 | Mixed-up of materials/components | Dental varnish has the possibility of having an unpleasant and off flavor. |
| Jul 6, 2018 | Class II | Z-0368-2019 | Mixed-up of materials/components | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253052 (Nagy Oral Technology Qinhuangdao Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080249.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Enamelast TM Fluoride Varnish is 5%sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132109 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132109: Enamelast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132109
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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