510(k) · Cleared
ClearedFiltek One Bulk Fill Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EBF Material, Tooth Shade, Resin
Cleared on Nov 28, 2016 as substantially equivalent to K141081 (3M Espe Dental Products, 2014) after a 13-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Nov 28, 2016
- Review
- 13 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083610 (2008). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
- 1 generation backK141081 Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
- This deviceK163207 Filtek One Bulk Fill Restorative3M Company · 2016
- Descendant · cites it directly · 0 of its ownK221255 SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation · 2022 · cites it directly0descendants
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 | K141081 | Filtek Bulk Fill Posterior Restroative | 3M Espe Dental Products | 2014 | — |
| 0 (this device) | K163207 | Filtek One Bulk Fill Restorative | 3M Company | 2016 | — |
| +1 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Kerr Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K141081 | Filtek Bulk Fill Posterior RestroativeSummary page 4…l Restorative Recommended Classification...... 21 CFR 872.3690 Tooth shade resin material Product Code: EBF Predicate Device: Filtek™ Bulk Fill Posterior Restorative (K141081) 3M™ Filtek™ One Bulk Fill Restorative 510(k) Page 34 of 276 Page 3 of 17 Description of Device: 3M™ Filtek™ O… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | 2022 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K221255 (Kerr Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K141081.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Direct anterior and posterior restorations (including occlusal surfaces)
Base/liner under direct restorations
Core build-ups
Splinting
Indirect restorations including inlays, onlays and veneers
Restorations of deciduous teeth
Extended fissure sealing in molars and premolars
Repair of defects in porcelain restorations, enamel, and temporaries
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163207: Filtek One Bulk Fill Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163207
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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