510(k) · Cleared
ClearedSignum opaque F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kulzer, LLC · EBF Material, Tooth Shade, Resin
Cleared on Sep 7, 2023 as substantially equivalent to K152373 (Vita Zahnfabrik H.Rauter GmbH & Co., 2015) after a 183-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Sep 7, 2023
- Review
- 183 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902115 (1990). 17 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 4 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 3 generations backK991220 Vitron HEspe Dental AG · 1999
- 2 generations backK992645 SinfonyEspe Dental AG · 1999
- 1 generation backK152373 VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co. · 2015
- This deviceK230644 Signum opaque FKulzer, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −4 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −3 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| −2 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| −1 | K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K152373 | VITA VM LC FlowSummary page 4…ber 872.3690 Product Code EBF | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K152373 VITAVM LC FLOW EBF Device Description Summary 21 CFR 807.92(a)(4) Signum opaque F is a light-curing, one component opaquer used… | 2015 |
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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- None of the 17 ancestors has a recall.
- 1 other device also cites its predicate K152373.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.
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/K230644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230644: Signum opaque F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230644
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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