510(k) · Cleared
Clearednuance UNIVERSAL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den-Mat Holdings, LLC · EBF Material, Tooth Shade, Resin
Cleared on Mar 24, 2017 as substantially equivalent to K063595 (Kuraray America, Inc., 2007) after a 151-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Mar 24, 2017
- Review
- 151 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931812 (1993). 53 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations between
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- 1 generation backK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- This deviceK162967 nuance UNIVERSALDen-Mat Holdings, LLC · 2017
Show all 9 generations
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 8 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 7 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 5 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 4 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- 1 generation backK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- This deviceK162967 nuance UNIVERSALDen-Mat Holdings, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −8 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −7 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −5 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −4 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −3 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −2 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| −1 | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| 0 (this device) | K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K063595 | Clearfil Majesty PosteriorSummary page 4…t 805 346 3700, X2932 hragus(@denmat.com October 21, 2016 nuance” UNIVERSAL Light-Curable Dental Restorative Material Material, Tooth Shade Resin (21 CFR 872.3690) K063595 CLEARFIL MAJESTY Posterior 13 Description of the Device nuance® UNIVERSAL is a Class II medical device, under… | 2007 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 53 ancestors has a recall.
- 2 other devices also cite its predicate K063595.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
1) Direct restorations of anterior or posterior teeth (Class I — Class V)
2) Diastema closures
3) Intraoral repairs of fractured crowns/bridges
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/K162967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162967: nuance UNIVERSAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162967
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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