510(k) · Cleared
ClearedCompolute Aplicap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental-Medizin GmbH & Co.Kg. · EMA Cement, Dental
Cleared on Feb 2, 1998 as substantially equivalent to K913966 (Espe GmbH (Us), 1992) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1990. 70 later devices descend from it.
- Decided
- Feb 2, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900510 (1990). 3 ancestors in all. 70 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 1 generation backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- This deviceK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- Descendant · cites it directly · 63 of its ownK020256 Unicem3M Espe AG Dental Products · 2002
- Descendant · 2 generations on · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 2 generations on · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K020256Unicem3M Espe AG Dental Products · 2002 · cites it directly63descendants
- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · 2 generations on37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
- K100756MALTA3M Espe AG Dental Products · 2010 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −1 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| 0 (this device) | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| +1 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| +2 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +2 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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? (6)
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 |
|---|---|---|---|
| * | K913966 | Sono (R) -CemSummary page 1…ers. The product is composed of powder and liquid portions. For composition, ESPE is claiming substantial equivalence to its previously cleared dental cement Sono®-Cem (K913966) and tooth shade resin material Pertac® II (K962440). The ingredients in ESPE’s Compolute® Aplicap® are contained in Sono®-Cem an… | 1992 |
| * | K962440 | Pertac II/Pertac II AplitipSummary page 1…rtions. For composition, ESPE is claiming substantial equivalence to its previously cleared dental cement Sono®-Cem (K913966) and tooth shade resin material Pertac® II (K962440). The ingredients in ESPE’s Compolute® Aplicap® are contained in Sono®-Cem and/or Pertac® II, with the exception of: (1) strontiu… | 1996 |
| * | — | Panavia® 21 Named without a submission number | |
| * | — | Variolink II Named without a submission number | |
| * | — | Scotchbond Resin Cement Named without a submission number | |
| * | — | Nexus dental cements Named without a submission number | |
| † | K973262 | Ketac-Fil Aplicap Plus | 1997 |
| † | K950203 | Protemp (R) Garant | 1995 |
What descends from it? (70)
See all 702 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K020256 (3M Espe AG Dental Products, 2002) has gone furthest, with 63 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 | — |
What is it indicated for?
Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers
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/K974458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974458: Compolute Aplicap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974458
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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