510(k) · Cleared
ClearedVITA Akzent LC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita Zahnfabrik GmbH H Rauter & CO · EBD Coating, Filling Material, Resin
Cleared on Nov 22, 2021 as substantially equivalent to K123761 (Innovation Meditech GmbH, 2013) after a 159-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- Nov 22, 2021
- Review
- 159 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123761 (2013). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK123761 Vita Enamic StainsInnovation Meditech GmbH · 2013
- This deviceK211854 VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO · 2021
- Descendant · cites it directly · 1 of its ownK240660 Signum composite flow; Signum universal bond; Signum metal bond…Kulzer, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK251587 VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | 2021 | — |
| +1 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum… | Kulzer, LLC | 2024 | — |
| +2 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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…Classification Name Coating Material for Resin Filling ▪ Regulation Number 21 CFR 872.3310 ▪ Product Code EBD Predicate Devices Vident’s VITA Enamic Stains– K123761 – Primary Predicate Device 1 === Page 5 ==… | 2013 |
| † | K133836 | Optiglaze Color | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite… | 2024 | 1 |
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?
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 AKZENT LC Indication range:
• Restorations made of hybrid ceramic
• Restorations made of light-curing veneering material
• Restorations made of CAD/CAM composites
• Prefabricated Teeth
• Denture bases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211854: VITA Akzent LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211854
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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