510(k) · Cleared
ClearedSimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
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 Aug 31, 2022 as substantially equivalent to K163207 (3M Company, 2016) and 1 other predicate after a 121-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 31, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940459 (1994). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- 3 generations backK981965 Flowable CompositeDentsply Intl. · 1998
- 2 generations backK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- 1 generation backK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- This deviceK221255 SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| −3 | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| −2 | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| −1 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| 0 (this device) | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Kerr Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K163207 | Filtek One Bulk Fill RestorativeSummary page 4…90 Device Class: II Product Code: EBF 3. Predicate Device (Primary): Proprietary Name: Filtek™ One Bulk Fill Restorative (K163207) Manufacturer: 3M ESPE Dental Products Common Name: Tooth Shade Resin Material Restorative Cl… | 2016 |
| * | K120453 | Filtek Bulk Fill Flowable RestorativeSummary page 4…2.3690 Device Class: II Product Code: EBF Predicate Device #2: Proprietary Name: Filtek™ Bulk Fill Flowable Restorative (K120453) Manufacturer: 3M ESPE Dental Products Common Name: Tooth Shade Resin Material Classifica… | 2012 |
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 28 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The SimpliShade Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
The SimpliShade Bulk Fill Flow is indicated for:
- Base/liner under Class I and Class II direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class ff and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221255: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221255
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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