510(k) · Cleared
ClearedDMC Composite 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Corporation · EBF Material, Tooth Shade, Resin
Cleared on Jan 20, 2011 after a 65-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 20, 2011
- Review
- 65 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Premise Named without a submission number | |
| * | — | Premise Flowable Named without a submission number | |
| * | — | Optibond Solo Plus Z Named without a submission number |
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.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
DMC Composite 2 High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, small endo access restorations, repair of porcelain restorations, repair of composite restorations and acrylic restorations, and repair of temporaries. DMC Composite 2 Low Viscosity is intended for Class I and 11(base/liner), Class III and Class V restorations. Additional indications include pit and fissure…
Read the full statement (99 words)
DMC Composite 2 High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, small endo access restorations, repair of porcelain restorations, repair of composite restorations and acrylic restorations, and repair of temporaries.
DMC Composite 2 Low Viscosity is intended for Class I and 11(base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occiusal build-ups in non-stress bearing areas, incisal abrasions, small endo access restorations, repair of composite and acrylic restorations, and repair of temporaries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103351: DMC Composite 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103351
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026