510(k) · Cleared
ClearedR&D Series Nova Compo N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · EBF Material, Tooth Shade, Resin
Cleared on Dec 20, 2019 as substantially equivalent to K042819 (Ivoclar Vivadent, Inc., 2004) and 1 other predicate after a 130-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 20, 2019
- Review
- 130 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943168 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943168 Clearfil AP-XKuraray Company, Ltd. · 1994
- 2 generations backK012740 Clearfil AP-XKuraray Medical, Inc. · 2001
- 1 generation backK061860 Clearfil Majesty EstheticKuraray Medical, Inc. · 2006
- This deviceK192178 R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943168 | Clearfil AP-X | Kuraray Company, Ltd. | 1994 | — |
| −2 | K012740 | Clearfil AP-X | Kuraray Medical, Inc. | 2001 | — |
| −1 | K061860 | Clearfil Majesty Esthetic | Kuraray Medical, Inc. | 2006 | — |
| 0 (this device) | K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K042819 | Tetric EvoceramSummary page 5…DEVICE 510(k) NUMBER PRODUCT CODE Ivoclar Vivadent, Incorporated Tetric Evoceram K042819 EBF Kuraray Medical, Inc. Clearfil Majesty Esthetic K061860 EBF… | 2004 |
| * | K061860 | Clearfil Majesty EstheticSummary page 5…Vivadent, Incorporated Tetric Evoceram K042819 EBF Kuraray Medical, Inc. Clearfil Majesty Esthetic K061860 EBF Indication for Use: R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid univer… | 2006 |
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 25 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 6 ancestors has a recall.
- 13 other devices also cite its predicate K042819.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
R&D Series Nova Compo N is a light–curing, radiopaque, nano–hybrid universal composite for anterior and posterior restorations. It is intended for professional use by below mentioned Indications for Use;
· Restorations of deciduous teeth
· Splinting of mobile teeth
· Restoration in the posterior region (Classes I and II)
· Anterior restorations (Classes III, IV)
· Class V restorations (cervical caries, root erosion, wedge-shaped defects)
· Extended fissure sealing in molars and premolars
· Veneering of discoloured anterior teeth
· Repair of composite and ceramic veneers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192178: R&D Series Nova Compo N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192178
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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