510(k) · Cleared
ClearedMultipurpose Resin Cement with Fluoride (MRCF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EMA Cement, Dental
Cleared on Apr 29, 1994 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Apr 29, 1994
- Review
- 87 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- Descendant · cites it directly · 11 of its ownK981965 Flowable CompositeDentsply Intl. · 1998
- Descendant · 2 generations on · 9 of its ownK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- Descendant · cites it directly · 8 of its ownK040906 Calibra CementDentsply Intl. · 2004
- Descendant · 2 generations on · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K981965Flowable CompositeDentsply Intl. · 1998 · cites it directly11descendants
- K083841Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009 · 2 generations on9descendants
- K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012 · 3 generations on8descendants
- K040906Calibra CementDentsply Intl. · 2004 · cites it directly8descendants
- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| +1 | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| +2 | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| +3 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| +1 | K040906 | Calibra Cement | Dentsply Intl. | 2004 | — |
| +2 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K981965 (Dentsply Intl., 1998) has gone furthest, with 11 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
https://510kreport.com/device/K940459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940459: Multipurpose Resin Cement with Fluoride (MRCF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940459
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026