510(k) · Cleared
ClearedUnicem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe Dental Products · EMA Cement, Dental
Cleared on Oct 25, 2006 as substantially equivalent to K002364 (Espe Dental AG, 2000) after a 79-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Oct 25, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002364 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002364 Protemp HEspe Dental AG · 2000
- This deviceK062292 Unicem3M Espe Dental Products · 2006
- Descendant · cites it directly · 2 of its ownK093338 Self Adhesive Composite Luting CementDmg USA, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK101787 Duolink IIBisco, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK250156 Choice 2 DCBisco, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002364 | Protemp H | Espe Dental AG | 2000 | — |
| 0 (this device) | K062292 | Unicem | 3M Espe Dental Products | 2006 | — |
| +1 | K093338 | Self Adhesive Composite Luting Cement | Dmg USA, Inc. | 2010 | — |
| +2 | K101787 | Duolink II | Bisco, Inc. | 2010 | — |
| +3 | K250156 | Choice 2 DC | Bisco, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (1)
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 |
|---|---|---|---|
| * | K002364 | Protemp HSummary page 2…-eugenol Common Name: S lf adhesive cement Predicate Device Unicem by 3M ESPE, K 002364 Description for the Premarket Notification Unicem is classified as a Dental cement othe:than… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093338 | Self Adhesive Composite Luting Cement | 2010 | 2 |
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?
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 fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneer and orthodontic strips.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062292: Unicem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062292
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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