510(k) · Cleared
ClearedHydro-Cast Versa-Temp Non-Eugenol Provisional Cement, Model 70010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kay See Dental Mfg. Co. · EMA Cement, Dental
Cleared on Feb 25, 1999 as substantially equivalent to K884081 (Scientific Pharmaceuticals, Inc., 1988) after a 37-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Feb 25, 1999
- Review
- 37 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884081 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK884081 Interim, Temporary CementScientific Pharmaceuticals, Inc. · 1988
- This deviceK990155 Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement, Model 70010Kay See Dental Mfg. Co. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884081 | Interim, Temporary Cement | Scientific Pharmaceuticals, Inc. | 1988 | — |
| 0 (this device) | K990155 | Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement, Model 70010 | Kay See Dental Mfg. Co. | 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 |
|---|---|---|---|
| * | K884081 | Interim, Temporary CementSummary page 3…emporary Cement Classification Name - Dental Cement (872.3275) Substantial equivalence claimed to - UNTIL eugenol free temporary polymeric composition cementing agent, K884081. Manufactured by SciPharm. Description of the device. The device is a syringe dispensing system that dispenses a eugenol free te… | 1988 |
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.
- 1 other device also cites its predicate K884081.
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?
Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily adhering crowns and bridges. Hydro-Cast Versa-Temp provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal of the patgrial from the interproximal areas, sulcular tissues and undercuts, and arigid ed wi removal of the temporary.
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/K990155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990155: Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement, Model 70010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990155
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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