510(k) · Cleared
ClearedMI Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · LBH Varnish, Cavity
Cleared on Dec 22, 2010 as substantially equivalent to K961893 (Pharmascience, Inc., 1996) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 22, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961893 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961893 DuraflorPharmascience, Inc. · 1996
- This deviceK102808 MI VarnishGC America, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961893 | Duraflor | Pharmascience, Inc. | 1996 | — |
| 0 (this device) | K102808 | MI Varnish | GC America, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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 |
|---|---|---|---|
| * | K961893 | DuraflorSummary page 1…Devices: Company Device K Number A.R. Medical Inc. Duraflor K96 1893 Pharmascience, Inc. 3M ESPE Dental Products Vanish Varnish, 5% Sodium K092141… | 1996 |
| * | K092141 | Vanish Varnish, 5% Sodium Fluoride White VarnishSummary page 1…cal Inc. Duraflor K96 1893 Pharmascience, Inc. 3M ESPE Dental Products Vanish Varnish, 5% Sodium K092141 Fluoride White Varnish ________ GC Corporation MI… | 2010 |
| † | K070854 | GC MI Paste Plus | 2007 |
| † | K875133 | Cavit-W | 1988 |
| † | K062683 | Enamel Pro Varnish | 2006 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K961893.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
MI Varnish is a fluoride varnish with RecaldentTM (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102808: MI Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102808
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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