510(k) · Cleared
ClearedBright Restorative Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmp, Ltd. · EBF Material, Tooth Shade, Resin
Cleared on Sep 28, 2012 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 28, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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. 2012, 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?
NANOCERAM - BRIGHT FLOW Fillings of minimally invasive cavities of all classes Fillings of small class I cavities Fillings of class Il-V cavities including V-shaped defects and cervical caries Extended fissure sealing Cavity lining - as the first layer for Class I and 11restorations Splinting of mobile teeth Blocking out of undercuts Small restorations of all types Repair of composite restorations and ceramic veneers BRIGHT FLOW CORE - BRIGHT HEAVY CORE…
Read the full statement (170 words)
NANOCERAM - BRIGHT FLOW
Fillings of minimally invasive cavities of all classes
Fillings of small class I cavities
Fillings of class Il-V cavities including V-shaped defects and cervical caries
Extended fissure sealing
Cavity lining - as the first layer for Class I and 11restorations
Splinting of mobile teeth
Blocking out of undercuts
Small restorations of all types
Repair of composite restorations and ceramic veneers
BRIGHT FLOW CORE - BRIGHT HEAVY CORE
Core build up of vital and non-vital teeth
Post cementation
BRIGHT LIGHT
Class I-V restorations
Reconstruction of affected anterior teeth
Veneering of discoloured anterior teeth
Splinting of mobile teeth
Repair of composite and ceramic veneers
BRIGHT LIGHT FLOW
Fillings of minimally invasive cavities of all classes
Fillings of class Il-V cavities including V-shaped defects and cervical caries
Extended fissure sealing
Splinting of mobile teeth
Blocking out of undercuts
Small restorations of all types
Repair of composite restorations and ceramic veneers
BRIGHT POSTERIOR
Direct posterior restorations (Class I and 11), including occlusal surfaces
Core build ups
Splinting of mobile teeth
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121915: Bright Restorative Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121915
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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