510(k) · Cleared
ClearedVitron M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on May 25, 1999 as substantially equivalent to K902115 (Kulzer, Inc., 1990) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1990. 60 later devices descend from it.
- Decided
- May 25, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902115 (1990). 60 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 1 generation backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- This deviceK990763 Vitron MEspe Dental AG · 1999
- Descendant · cites it directly · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
- Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 2 generations on · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- Descendant · 4 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K992645SinfonyEspe Dental AG · 1999 · cites it directly59descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · 2 generations on12descendants
- K112118DreambondBisco, Inc. · 2011 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −1 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| 0 (this device) | K990763 | Vitron M | Espe Dental AG | 1999 | — |
| +1 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +2 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| +4 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · 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 |
|---|---|---|---|
| * | K902115 | Palapress (R) Vario ResinSummary page 1…e relining, repairing, or rebasing resin Common Name:.......cccccevvvveercenenesnennn. Denture base material Predicate Devices PALAPRESS® VARIO by Kulzer.............. K 902115 LIQCRYLIC® by Dentsply .............co........ K 972573 Description for the Premarket Notification VITRON® M is classified as a… | 1990 |
| * | K972573 | Liqcrylic Pro Dental ResinSummary page 1…....cccccevvvveercenenesnennn. Denture base material Predicate Devices PALAPRESS® VARIO by Kulzer.............. K 902115 LIQCRYLIC® by Dentsply .............co........ K 972573 Description for the Premarket Notification VITRON® M is classified as a denture relining, repairing, or rebasing resin (21 C.F.… | 1997 |
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992645 | Sinfony | 1999 | 59 |
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K992645 (Espe Dental AG, 1999) has gone furthest, with 59 descendants of its own.
- 3 other devices also cite its predicate K902115.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
Denture base material for:
Completion of metal frameworks
Partial and total denture rebasing
Extension of partial dentures
Repairs
Fabrication of partial and total dentures
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/K990763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990763: Vitron M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990763
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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