510(k) · Cleared
ClearedVita Enamic Stains
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovation Meditech GmbH · EBD Coating, Filling Material, Resin
Cleared on Mar 1, 2013 after an 84-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Mar 1, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK123761 Vita Enamic StainsInnovation Meditech GmbH · 2013
- Descendant · cites it directly · 2 of its ownK211854 VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO · 2021
- Descendant · 2 generations on · 1 of its ownK240660 Signum composite flow; Signum universal bond; Signum metal bond…Kulzer, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK251587 VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026
- Descendant · cites it directly · 0 of its ownK162408 Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH · 2018
Most influential descendants
Showing 4 of 4 · See all- K211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO · 2021 · cites it directly2descendants
- K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…Kulzer, LLC · 2024 · 2 generations on1descendant
- K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026 · 3 generations on0descendants
- K162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123761 | Vita Enamic Stains | Innovation Meditech GmbH | 2013 | — |
| +1 | K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | 2021 | — |
| +2 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum… | Kulzer, LLC | 2024 | — |
| +3 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026 | — |
| +1 | K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (4)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211854 (Vita Zahnfabrik GmbH H Rauter & CO, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.
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/K123761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123761: Vita Enamic Stains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123761
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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