510(k) · Cleared
ClearedPremier Implant Cement, Model 3001450
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Dental Products Co. · EMA Cement, Dental
Cleared on Jan 26, 2004 after a 104-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jan 26, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK033309 Premier Implant Cement, Model 3001450Premier Dental Products Co. · 2004
- Descendant · cites it directly · 1 of its ownK134021 Estemp Implant, Estemp ClearSpident Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK262983 EsTemp ImplantSpident Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK122549 Dento TempItena Clinical · 2013
- Descendant · cites it directly · 0 of its ownK101044 Retrieve Implant CementParkell, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K134021Estemp Implant, Estemp ClearSpident Co., Ltd. · 2014 · cites it directly1descendant
- K262983EsTemp ImplantSpident Co., Ltd. · 2026 · 2 generations on0descendants
- K122549Dento TempItena Clinical · 2013 · cites it directly0descendants
- K101044Retrieve Implant CementParkell, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033309 | Premier Implant Cement, Model 3001450 | Premier Dental Products Co. | 2004 | — |
| +1 | K134021 | Estemp Implant, Estemp Clear | Spident Co., Ltd. | 2014 | — |
| +2 | K262983 | EsTemp Implant | Spident Co., Ltd. | 2026 | — |
| +1 | K122549 | Dento Temp | Itena Clinical | 2013 | — |
| +1 | K101044 | Retrieve Implant Cement | Parkell, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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, K134021 (Spident Co., Ltd., 2014) has gone furthest, with 1 descendant 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?
Premier Implant CementTM is a non-eugenol temporary cement for luting implant-retained crowns.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033309 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033309: Premier Implant Cement, Model 3001450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033309
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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