510(k) · Cleared
ClearedMALTA
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 2, 2010 as substantially equivalent to K020256 (3M Espe AG Dental Products, 2002) and 3 other predicates after a 77-day review. Its family tree reaches back 9 generations to 1993. 19 later devices descend from it.
- Decided
- Jun 2, 2010
- Review
- 77 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). 19 later devices descend from it, 5 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 deviceK100756 MALTA3M Espe AG Dental Products · 2010
- Descendant · cites it directly · 8 of its ownK110508 Suglue-103M Espe AG · 2011
- Descendant · 2 generations on · 5 of its ownK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK120379 Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK200798 G-Cem OneGC America, Inc. · 2020
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 deviceK100756 MALTA3M Espe AG Dental Products · 2010
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K110508Suglue-103M Espe AG · 2011 · cites it directly8descendants
- K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016 · 2 generations on5descendants
- K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc. · 2012 · cites it directly5descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on4descendants
- K200798G-Cem OneGC America, Inc. · 2020 · 3 generations on3descendants
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) | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| +1 | K110508 | Suglue-10 | 3M Espe AG | 2011 | — |
| +2 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
| +1 | K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement… | Kuraray Medical, Inc. | 2012 | — |
| +2 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +3 | K200798 | G-Cem One | GC America, Inc. | 2020 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K020256 | UnicemSummary page 1…........................ Self adhesive cement Predicate Devices Unicem by 3M ESPE, Germany ................. K020256, K094007 Panavia F 2.0 by Kuraray Medical Inc., Japan ...... K032455 Maxcem 2 by Kerr Corporation, U.S.A., pr… | 2002 |
| * | K094007 | Unicem Cleared while this submission was under review Summary page 1…............... Self adhesive cement Predicate Devices Unicem by 3M ESPE, Germany ................. K020256, K094007 Panavia F 2.0 by Kuraray Medical Inc., Japan ...... K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably… | 2010 |
| * | K032455 | Panavia F 2.0Summary page 1…Devices Unicem by 3M ESPE, Germany ................. K020256, K094007 Panavia F 2.0 by Kuraray Medical Inc., Japan ...... K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcenm Elite............K073209 Description for the… | 2003 |
| * | K073209 | Maxcem 2Summary page 1…007 Panavia F 2.0 by Kuraray Medical Inc., Japan ...... K032455 Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcenm Elite............K073209 Description for the Premaiket Notification Malta is classified as a Dental cement other than zinc oxide-eugenol… | 2008 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110508 | Suglue-10 | 2011 | 8 |
| K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix… | 2012 | 5 |
| K120378 | Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix… | 2012 | 1 |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | 2025 | 0 |
| K192992 | Suglue 3 | 2019 | 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, K110508 (3M Espe AG, 2011) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K020256.
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 cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis);
Final cementing of posts and screws;
Final cementation of all-ceramic, composite, or metal restorations on implant abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100756: MALTA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100756
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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