510(k) · Cleared
ClearedDimer Acid Derived Nano-Hybrid Composite Restorative Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novocol, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Sep 13, 2007 as substantially equivalent to K946307 (Confi-Dental Products Co., 1995) and 2 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Sep 13, 2007
- Review
- 41 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K920425 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920425 3M Brand Restorative Z1003M Company · 1992
- This deviceK072150 Dimer Acid Derived Nano-Hybrid Composite Restorative MaterialNovocol, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920425 | 3M Brand Restorative Z100 | 3M Company | 1992 | — |
| 0 (this device) | K072150 | Dimer Acid Derived Nano-Hybrid Composite Restorative Material | Novocol, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K946307 | Cyrstalline L3 Multi-Use Hybrid CompositeSummary page 1…Steve Rudolph Name: Dimer Acid Derived Nanohybrid Composite Classification name: Tooth shade resin material, 872.3690 Predicate devices: Crystalline L3 Multiuse hybrid K946307 3M Brand restorative K920425 Grandio K051867 Device description: Dimer acid derived nanoh… | 1995 |
| * | K920425 | 3M Brand Restorative Z100Summary page 1…id Composite Classification name: Tooth shade resin material, 872.3690 Predicate devices: Crystalline L3 Multiuse hybrid K946307 3M Brand restorative K920425 Grandio K051867 Device description: Dimer acid derived nanohybrid composite is for use in all dental cavity c… | 1992 |
| * | K051867 | GrandioSummary page 1…oth shade resin material, 872.3690 Predicate devices: Crystalline L3 Multiuse hybrid K946307 3M Brand restorative K920425 Grandio K051867 Device description: Dimer acid derived nanohybrid composite is for use in all dental cavity classes. The composite is a single li… | 2005 |
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?
- 1 of the 3 ancestors has a recall of any class.
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?
"Dimer Acid Derived Nanohybrid Composite" is a light cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides simple esthetics since it is formulated in shades matching the VITA Lumin Shade guide. This low shrinkage nanohybrid composite can be used in all classes of direct dental restorations, Class 1,11, 111, IV, and V.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072150: Dimer Acid Derived Nano-Hybrid Composite Restorative Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072150
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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