510(k) · Cleared
ClearedNano Varnish, Plaquit, Lightpaint on Surface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dreve Dentamid GmbH · EBD Coating, Filling Material, Resin
Cleared on Apr 5, 2018 as substantially equivalent to K123761 (Innovation Meditech GmbH, 2013) after a 584-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Apr 5, 2018
- Review
- 584 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123761 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK123761 Vita Enamic StainsInnovation Meditech GmbH · 2013
- This deviceK162408 Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123761 | Vita Enamic Stains | Innovation Meditech GmbH | 2013 | — |
| 0 (this device) | K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | 2018 | — |
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 EBD? 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 EBD device
- #1 K254091 Glossy Coat (15ML)score 11.4 · 2 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 |
|---|---|---|---|
| * | K123761 | Vita Enamic StainsSummary page 4….3310 • Product Code: EBO Primary Predicate K123761 VITA ENAMIC® Glaze Device: Device Description… | 2013 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K123761.
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · EBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBD
76in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBD
No recall names EBD since 2007.
Adverse event reports per year · EBD
5in 2023
MAUDE reports naming product code EBD, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 76 | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Varnish for final coating for resin temporaries to produce a smooth and shiny surface.
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/K162408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162408: Nano Varnish, Plaquit, Lightpaint on Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162408
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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