510(k) · Cleared
ClearedSynergy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltene/Whaledent, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Mar 9, 1998 after a 103-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 9, 1998
- Review
- 103 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.
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?
SYNERGY Shades (enamel) A1/D2, A2/B2, A3/D3, A4/M5, A3.5/B3, C2/C3 is indicated for: direct filling of class I, II, III, IV and V cavities reconstruction of natural enamel and dentine reconstruction of fractured anteriors sealing of extended fissure in molars and premolars stabilization of mobile anteriors repair of veneer facings fixation of splints banded bridges esthetic Synergy Compact (dentin) A2/B2, A3/D3, A3.5/B3 is specifically indicated for…
Read the full statement (150 words)
SYNERGY Shades (enamel) A1/D2, A2/B2, A3/D3, A4/M5, A3.5/B3, C2/C3 is indicated for:
direct filling of class I, II, III, IV and V cavities
reconstruction of natural enamel and dentine
reconstruction of fractured anteriors
sealing of extended fissure in molars and premolars
stabilization of mobile anteriors
repair of veneer facings
fixation of splints
banded bridges
esthetic
Synergy Compact (dentin) A2/B2, A3/D3, A3.5/B3 is specifically indicated for:
core reconstruction in highly esthetic class I, II, III restorations, which are subsequently covered with a more translucent material
direct class V fillings
direct filling of opaque teeth
palatinal of class IV restorations
core build-ups
Shape and color corrections to improve esthetics
SYNERGY Transparent is specifically indicated for:
reconstruction of incisal edges in class IV fillings
translucent surface layers in all classes
covering characterizations
Super White is especially indicated for:
restoration of whitened teeth
restoration of deciduous teeth
characterization of chalk spots
veneering of anteriors
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974465: Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974465
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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