510(k) · Cleared
ClearedKetac-Molar Aplicap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH & Co. Kg. · EMA Cement, Dental
Cleared on May 16, 1996 as substantially equivalent to K874788 (Espe GmbH (Us), 1988) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1984. 8 later devices descend from it.
- Decided
- May 16, 1996
- Review
- 66 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843566 (1984). 2 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK843566 Ketac-SilverEspe GmbH (Us) · 1984
- This deviceK960954 Ketac-Molar AplicapEspe GmbH & Co. Kg. · 1996
- Descendant · cites it directly · 1 of its ownK994251 Ketac-Molar QuickEspe Dental AG · 2000
- Descendant · cites it directly · 1 of its ownK992966 ReferenceEspe Dental AG · 1999
- Descendant · cites it directly · 0 of its ownK123826 Vitro MolarDfl Industria E Comercio SA · 2013
- Descendant · cites it directly · 0 of its ownK101493 Advanced Glass Ionomer (K-130) RestorativeDentsply International, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK091826 Elegant3M Espe AG Dental Products · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K994251Ketac-Molar QuickEspe Dental AG · 2000 · cites it directly1descendant
- K992966ReferenceEspe Dental AG · 1999 · cites it directly1descendant
- K123826Vitro MolarDfl Industria E Comercio SA · 2013 · cites it directly0descendants
- K101493Advanced Glass Ionomer (K-130) RestorativeDentsply International, Inc. · 2010 · cites it directly0descendants
- K091826Elegant3M Espe AG Dental Products · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843566 | Ketac-Silver | Espe GmbH (Us) | 1984 | — |
| 0 (this device) | K960954 | Ketac-Molar Aplicap | Espe GmbH & Co. Kg. | 1996 | — |
| +1 | K994251 | Ketac-Molar Quick | Espe Dental AG | 2000 | — |
| +1 | K992966 | Reference | Espe Dental AG | 1999 | — |
| +1 | K123826 | Vitro Molar | Dfl Industria E Comercio SA | 2013 | — |
| +1 | K101493 | Advanced Glass Ionomer (K-130) Restorative | Dentsply International, Inc. | 2010 | — |
| +2 | K091826 | Elegant | 3M Espe AG Dental Products | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K874788 | Ketac-Bond AplicapSummary page 1…FFECTIVENESS ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for dental cement material, tradenamed Ketac-Bond® Aplicap® (K874788) and Ketac- Silver® Aplicap (K843566), to create slightly modified glass ionomer cement material, referred to by the tradename Ke… | 1988 |
| * | K843566 | Ketac-SilverSummary page 1…0(k) premarket notification for modifications to its 510(k) submissions for dental cement material, tradenamed Ketac-Bond® Aplicap® (K874788) and Ketac- Silver® Aplicap (K843566), to create slightly modified glass ionomer cement material, referred to by the tradename Ketac- Molar® Aplicap®. The reason for… | 1984 |
What descends from it? (8)
6 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K994251 (Espe Dental AG, 2000) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.
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/K960954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960954: Ketac-Molar Aplicap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960954
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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