510(k) · Cleared
Clearedels extra low shrinkage® composite & els extra low shrinkage® flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saremco Dental AG · EBF Material, Tooth Shade, Resin
Cleared on Jun 27, 2024 as substantially equivalent to K213339 (Hdi, Inc., 2022) after a 93-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Jun 27, 2024
- Review
- 93 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083610 (2008). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K083610 | Filtek Supreme Ultra Universal Restorative | 3M Company | 2008 | — |
| −1 | K213339 | DENU Composite Resin, DENU Flow Resin | Hdi, Inc. | 2022 | — |
| 0 (this device) | K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | Saremco Dental AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K213339 | DENU Composite Resin, DENU Flow ResinSummary page 5…Resin Material – 21 CFR 872.3690 Regulation Number Product Code EBF Predicate Devices DENU Composite Resin (HDI, Inc.) – K213339 – Primary Predicate Brilliant EverGlow Flow (Coltene/Whaledent AG) – K190597 – Reference Device Brilliant Componeer (Co… | 2022 |
| † | K190597 | BRILLIANT EverGlow Flow | 2019 |
| † | K191385 | Brilliant Componeer | 2019 |
| † | K091635 | Venus Diamond Flow | 2009 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- None of the 3 ancestors has a 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. 2024, 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?
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition. els extra low shrinkage® composite is indicated for: Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth Indirect anterior and posterior restorations including inlays, onlays and veneers Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations…
Read the full statement (134 words)
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
Indirect anterior and posterior restorations including inlays, onlays and veneers
Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
Splinting
els extra low shrinkage® flow is indicated for:
Restorations with minimally invasive preparation technique
Restorations of small cavities and extended fissure sealing
Alternate restorations for undercut cavities
Restorations of class III - V including wedged shaped defects and cervical caries
Repair of fillings, veneers and methacrylate-based temporary restorations
First layer of fillings for Class I and II
Interlocking of loosened teeth
Adhesive attachment of indirect composite and ceramic restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240823: els extra low shrinkage® composite & els extra low shrinkage® flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240823
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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