510(k) · Cleared
ClearedUltracaps S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sdi, Ltd. · OIV Dental Amalgam
Cleared on Jul 10, 2008 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 10, 2008
- Review
- 66 days
- Class
- Class II
- Product code
- OIV
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 OIV? 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 OIV device
- #1 K223182 Arial Dental, Mistral Dental Amalgam, World…score 5.3 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All OIV devicesOIV Dental Amalgam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OIV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OIV
Too few OIV 510(k)s in any year since 2007 to give a median.
Recalls per year · OIV
No recall names OIV since 2007.
Adverse event reports per year · OIV
1in 2024
MAUDE reports naming product code OIV, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for tooth restorations as a treatment for dental carries and other use in stress bearing restorations (Class I and Class Il), when materials or restoration techniques are 4not indicated.
For professional use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081273: Ultracaps S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026