510(k) · Cleared
ClearedNew Luting Cement Material (NLC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EMA Cement, Dental
Cleared on Aug 29, 1994 after a 185-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Aug 29, 1994
- Review
- 185 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK940914 New Luting Cement Material (NLC)Dentsply Intl. · 1994
- Descendant · cites it directly · 5 of its ownK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
- Descendant · 2 generations on · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK162960 TotalC-RamItena Clinical · 2017
- Descendant · 3 generations on · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K012316Permacem / Permacem DualDmg USA, Inc. · 2001 · cites it directly5descendants
- K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013 · 2 generations on1descendant
- K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · 2 generations on1descendant
- K162960TotalC-RamItena Clinical · 2017 · 3 generations on0descendants
- K063444Total Etch Bonding AgentDmg USA, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940914 | New Luting Cement Material (NLC) | Dentsply Intl. | 1994 | — |
| +1 | K012316 | Permacem / Permacem Dual | Dmg USA, Inc. | 2001 | — |
| +2 | K121804 | Provitemp, Dentotemp, Totalcem, Dentocem | Itena Clinical | 2013 | — |
| +2 | K041960 | Composite/Compomer Repair Kit | Dmg USA, Inc. | 2004 | — |
| +3 | K162960 | TotalC-Ram | Itena Clinical | 2017 | — |
| +3 | K063444 | Total Etch Bonding Agent | Dmg USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
3 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, K012316 (Dmg USA, Inc., 2001) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K940914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940914: New Luting Cement Material (NLC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940914
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026