510(k) · Cleared
Recalled · Class II · 2013Maxcem 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Corporation · MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Cleared on Jan 29, 2008 after a 76-day review. The FDA summary names its predicate without a number. 27 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 29, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- MZW
- Recalls
- 3
- Predicates
- 0
27 later devices descend from it, 6 citing it directly.
- This deviceK073209 Maxcem 2Kerr Corporation · 2008
- Descendant · cites it directly · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
- Descendant · cites it directly · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
- Descendant · 2 generations on · 8 of its ownK110508 Suglue-103M Espe AG · 2011
- Descendant · 3 generations on · 5 of its ownK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK120379 Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K094007Unicem3M Espe AG Dental Products · 2010 · cites it directly22descendants
- K100756MALTA3M Espe AG Dental Products · 2010 · cites it directly19descendants
- K110508Suglue-103M Espe AG · 2011 · 2 generations on8descendants
- K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016 · 3 generations on5descendants
- K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073209 | Maxcem 2 | Kerr Corporation | 2008 | — |
| +1 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| +1 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| +2 | K110508 | Suglue-10 | 3M Espe AG | 2011 | — |
| +3 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
| +2 | K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement… | Kuraray Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 MZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Maxcem Named without a submission number | |
| * | — | Nexus 3 Named without a submission number | |
| * | — | Optibond Solo Plus 3 Named without a submission number |
What descends from it? (27)
See all 276 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2013 | Class II | Z-1076-2013 | Nonconforming Material/Component | Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter… |
| Nov 10, 2011 | Not classified | Z-0390-2012 | Pending | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
| Feb 3, 2011 | Not classified | Z-0915-2012 | Nonconforming Material/Component | The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K094007 (3M Espe AG Dental Products, 2010) has gone furthest, with 22 descendants of its own.
How does its category compare?
All MZW devicesMZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MZW
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MZW
Too few MZW 510(k)s in any year since 2007 to give a median.
Recalls per year · MZW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MZW
1in 2015
MAUDE reports naming product code MZW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Maxcem 2 is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers*. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restorations to implants.
* Adhesive application on the prep is required for veneer cementation using Maxcem 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073209: Maxcem 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073209
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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