510(k) · Cleared
ClearedMaxcem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · EMA Cement, Dental
Cleared on Jul 21, 2004 after a 49-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Jul 21, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK041474 MaxcemSybron Dental Specialties, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK060698 Cement-IT All Purpose, Model N97Pentron Clinical Technologies · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK073173 Self-Adhesive Resin CementDentsply Interntional · 2008
- 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 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K081583Clearfil SA CementKuraray Medical, Inc. · 2008 · cites it directly9descendants
- K060698Cement-IT All Purpose, Model N97Pentron Clinical Technologies · 2006 · cites it directly8descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · 2 generations on6descendants
- K073173Self-Adhesive Resin CementDentsply Interntional · 2008 · cites it directly6descendants
- 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) | K041474 | Maxcem | Sybron Dental Specialties, Inc. | 2004 | — |
| +1 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| +1 | K060698 | Cement-IT All Purpose, Model N97 | Pentron Clinical Technologies | 2006 | 2 |
| +2 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +1 | K073173 | Self-Adhesive Resin Cement | Dentsply Interntional | 2008 | — |
| +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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | — | UniCem Named without a submission number |
What descends from it? (25)
See all 254 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?
- Of its descendants, K081583 (Kuraray Medical, Inc., 2008) has gone furthest, with 9 descendants of its own.
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?
MaxCem is intended for indirect cementation of porcelain, resin and metal-based inlays,
onlays, crowns, bridges and posts. The material is not recommended for use on veneer
indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041474: Maxcem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041474
Report an extraction error
Are you the manufacturer?
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