510(k) · Cleared
ClearedSternomega Temporary Cement Automix NE, Model 220282/220281
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterngold/Implamed · EMA Cement, Dental
Cleared on Jan 8, 1999 as substantially equivalent to K970774 (Foremost Dental Mfg., Inc., 1997) after a 35-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 8, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970774 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970774 Tempocem NE (Multiple)Foremost Dental Mfg., Inc. · 1997
- This deviceK984340 Sternomega Temporary Cement Automix NE, Model 220282/220281Sterngold/Implamed · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970774 | Tempocem NE (Multiple) | Foremost Dental Mfg., Inc. | 1997 | — |
| 0 (this device) | K984340 | Sternomega Temporary Cement Automix NE, Model 220282/220281 | Sterngold/Implamed | 1999 | — |
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 |
|---|---|---|---|
| * | K970774 | Tempocem NE (Multiple)Summary page 1…tomix NE is substantially equivalent to the TempoCem NE temporary dental cement marketed by Foremost Dental Manufacturing, Inc. which was cleared for marketing by FDA in K970774. Product Description: The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the tempora… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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?
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984340: Sternomega Temporary Cement Automix NE, Model 220282/220281.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984340
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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