510(k) · Cleared
ClearedParacem Universal DC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltene/Whaledent AG · EMA Cement, Dental
Cleared on Nov 9, 2005 after a 13-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Nov 9, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK053040 Paracem Universal DCColtene/Whaledent AG · 2005
- Descendant · cites it directly · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK222581 Stela Automix SystemSdi Limited · 2022
- Descendant · 2 generations on · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
- Descendant · 2 generations on · 0 of its ownK242097 DenMat Bulk Fill CompositeDen-Mat Holdings, LLC · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · cites it directly3descendants
- K222581Stela Automix SystemSdi Limited · 2022 · cites it directly1descendant
- K171449MetacemMeta Biomed Co., Ltd. · 2018 · 2 generations on1descendant
- K261166Dia-CemDiaDent Group International · 2026 · 3 generations on0descendants
- K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053040 | Paracem Universal DC | Coltene/Whaledent AG | 2005 | — |
| +1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +1 | K222581 | Stela Automix System | Sdi Limited | 2022 | — |
| +2 | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +3 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
| +2 | K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (8)
4 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, K081913 (Meta Biomed Co., Ltd., 2008) has gone furthest, with 3 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?
ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053040: Paracem Universal DC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053040
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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