510(k) · Cleared
ClearedNano Composite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmedent, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Apr 16, 2007 as substantially equivalent to K042819 (Ivoclar Vivadent, Inc., 2004) after a 46-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it.
- Decided
- Apr 16, 2007
- Review
- 46 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042819 (2004). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- This deviceK070583 Nano CompositeCosmedent, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK080305 Nexcomp and Meta EtchantMeta Biomed Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK181689 NexcompMeta Biomed Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK163480 Renamel NANO +plusCosmedent, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| 0 (this device) | K070583 | Nano Composite | Cosmedent, Inc. | 2007 | — |
| +1 | K080305 | Nexcomp and Meta Etchant | Meta Biomed Co., Ltd. | 2008 | — |
| +2 | K181689 | Nexcomp | Meta Biomed Co., Ltd. | 2018 | — |
| +1 | K163480 | Renamel NANO +plus | Cosmedent, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K042819 | Tetric EvoceramSummary page 1…TRADE NAME: Tetric EvoCeram COMMON NAME: Nano-hybrid Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF) 510(k) Number: K042819 SUBSTANTIAL EQUIVALENCE SUMMARY Cosnltdent… | 2004 |
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?
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of
anterior teeth, splinting, and repair of composite or ceramic restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070583: Nano Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070583
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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