510(k) · Cleared
ClearedVITA VM LC Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita Zahnfabrik H.Rauter GmbH & Co. · EBF Material, Tooth Shade, Resin
Cleared on Dec 30, 2015 as substantially equivalent to K961434 (Vident, 1996) and 2 other predicates after a 131-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 30, 2015
- Review
- 131 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902115 (1990). 16 ancestors in all, the oldest K833757 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 3 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 2 generations backK991220 Vitron HEspe Dental AG · 1999
- 1 generation backK992645 SinfonyEspe Dental AG · 1999
- This deviceK152373 VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co. · 2015
- 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
- Descendant · cites it directly · 0 of its ownK230644 Signum opaque FKulzer, LLC · 2023
Most influential descendants
Showing 3 of 3 · See all- K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…Kulzer, LLC · 2024 · cites it directly1descendant
- K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026 · 2 generations on0descendants
- K230644Signum opaque FKulzer, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −3 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −2 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| −1 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| 0 (this device) | K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015 | — |
| +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 | — |
| +1 | K230644 | Signum opaque F | Kulzer, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K961434 | Vita Zeta Crown and Bridge Acrylic Veneering SystemSummary page 4…e Resin Material Regulation Number 21 CFR 872.3690 Product Code EBF Predicate Devices VITA Zeta® (VITA Zahnfabrik GmbH) – K961434 – Primary Predicate SR Nexco® (Ivoclar Vivadent, AG) – K123304 – Reference Predicate SINFONY® (ESPE Dental, AG) –… | 1996 |
| * | K123304 | SR Nexco Paste Layering Materials, SR Nexco Opaquer, SR Nexco Liner-SR Nexco Connect, SR…Summary page 4… Product Code EBF Predicate Devices VITA Zeta® (VITA Zahnfabrik GmbH) – K961434 – Primary Predicate SR Nexco® (Ivoclar Vivadent, AG) – K123304 – Reference Predicate SINFONY® (ESPE Dental, AG) – K992645 – Reference Predicate VITA VM® LC Flow - 510(k) Premarket N… | 2013 |
| * | K992645 | SinfonySummary page 4…Zeta® (VITA Zahnfabrik GmbH) – K961434 – Primary Predicate SR Nexco® (Ivoclar Vivadent, AG) – K123304 – Reference Predicate SINFONY® (ESPE Dental, AG) – K992645 – Reference Predicate VITA VM® LC Flow - 510(k) Premarket Notification Page 1 === Page… | 1999 |
What descends from it? (3)
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K240660 (Kulzer, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K961434.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
Individualization of and layering on VITA ENAMIC®
Layering-over long-term temporaries made from VITA CAD-Temp®
Individualization of acrylic teeth
Reproduction of gingival components
Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
Veneering of removable and partially removable dentures (according to the manufacturer‘s information)
Inlays
Veneers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152373: VITA VM LC Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152373
Report an extraction error
Are you the manufacturer?
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