510(k) · Cleared
ClearedUnicem HM
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 Jun 22, 2010 as substantially equivalent to K094007 (3M Espe AG Dental Products, 2010) and 3 other predicates after an 82-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Jun 22, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K931812 (1993). 30 ancestors in all, the oldest K871636 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations between
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 1 generation backK094007 Unicem3M Espe AG Dental Products · 2010
- This deviceK100908 Unicem HM3M Espe AG Dental Products · 2010
- Descendant · cites it directly · 0 of its ownK152691 EDS Universal CementEssential Dental Systems, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 8 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 7 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 5 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 4 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 1 generation backK094007 Unicem3M Espe AG Dental Products · 2010
- This deviceK100908 Unicem HM3M Espe AG Dental Products · 2010
Most influential descendants
Showing 1 of 1 · See all- K152691EDS Universal CementEssential Dental Systems, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −8 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −7 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −5 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −4 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −3 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −2 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −1 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| 0 (this device) | K100908 | Unicem HM | 3M Espe AG Dental Products | 2010 | — |
| +1 | K152691 | EDS Universal Cement | Essential Dental Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K094007 | Unicem Cleared while this submission was under review Summary page 1…eugenol Common Name:.............................Self adhesive cement Predicate Devices Unicem Aplicap/Maxicap by 3M ESPE AG, Germany .....K094007, K020256 Panavia F 2.0 by Kuraray Medical Inc., Japan............K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably markete… | 2010 |
| * | K020256 | UnicemSummary page 1…eugenol Common Name:.............................Self adhesive cement Predicate Devices Unicem Aplicap/Maxicap by 3M ESPE AG, Germany .....K094007, K020256 Panavia F 2.0 by Kuraray Medical Inc., Japan............K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxc… | 2002 |
| * | K032455 | Panavia F 2.0Summary page 1…...Self adhesive cement Predicate Devices Unicem Aplicap/Maxicap by 3M ESPE AG, Germany .....K094007, K020256 Panavia F 2.0 by Kuraray Medical Inc., Japan............K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite ................. K073209 Des… | 2003 |
| * | K073209 | Maxcem 2Summary page 1…256 Panavia F 2.0 by Kuraray Medical Inc., Japan............K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite ................. K073209 Description for the Premarket Notification Unicem NM is classified as a Dental cement other than zinc oxide-euge… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152691 | EDS Universal Cement | 2016 | 0 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K152691 (Essential Dental Systems, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K094007.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis)
Final cementation of post and screws
Final cementation of ceramic, composite or metal restorations on implant abutments
Cementation of abutments made of LavaTM zirconium oxide ceramic
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100908: Unicem HM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100908
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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