510(k) · Cleared
ClearedUnicem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · EMA Cement, Dental
Cleared on Mar 25, 2002 as substantially equivalent to K974458 (Espe Dental-Medizin GmbH & Co.Kg., 1998) and 4 other predicates after a 60-day review. Its family tree reaches back 3 generations to 1990. 63 later devices descend from it.
- Decided
- Mar 25, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K900510 (1990). 8 ancestors in all, the oldest K873882 (1988). 63 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 2 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 1 generation backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- This deviceK020256 Unicem3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · cites it directly · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 2 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · cites it directly · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
- Descendant · 3 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · cites it directly37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · cites it directly35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 2 generations on34descendants
- K100756MALTA3M Espe AG Dental Products · 2010 · cites it directly19descendants
- K112118DreambondBisco, Inc. · 2011 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −2 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −1 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| 0 (this device) | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| +1 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +1 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +2 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +1 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| +3 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 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 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K974458 | Compolute AplicapSummary page 1…Affairs 011-49-8152-700 1395 011-49-8152-700 1869 [email protected] January 21, 2002 Unicem Dental cement other than zinc oxide- eugenol Self adhesive cement K 974458 K 897188 K 010781 K 002364 K 873882 Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275… | 1998 |
| * | K897188 | Ketac-Cem MaxicapSummary page 1…011-49-8152-700 1395 011-49-8152-700 1869 [email protected] January 21, 2002 Unicem Dental cement other than zinc oxide- eugenol Self adhesive cement K 974458 K 897188 K 010781 K 002364 K 873882 Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275]b]) beca… | 1990 |
| * | K010781 | 3M Espe HaurSummary page 1…52-700 1395 011-49-8152-700 1869 [email protected] January 21, 2002 Unicem Dental cement other than zinc oxide- eugenol Self adhesive cement K 974458 K 897188 K 010781 K 002364 K 873882 Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275]b]) because it is… | 2001 |
| * | K002364 | Protemp HSummary page 1…95 011-49-8152-700 1869 [email protected] January 21, 2002 Unicem Dental cement other than zinc oxide- eugenol Self adhesive cement K 974458 K 897188 K 010781 K 002364 K 873882 Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275]b]) because it is a device… | 2000 |
| * | K873882 | AlkalinerSummary page 1…-8152-700 1869 [email protected] January 21, 2002 Unicem Dental cement other than zinc oxide- eugenol Self adhesive cement K 974458 K 897188 K 010781 K 002364 K 873882 Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275]b]) because it is a device composed… | 1988 |
What descends from it? (63)
See all 638 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 12 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K043043 (3M Espe AG Dental Products, 2005) has gone furthest, with 37 descendants of its own.
- 1 other device also cites its predicate K974458.
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, veneers and orthodontic strips
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/K020256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020256: Unicem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020256
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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