# K081273: Ultracaps S

- Pathway: 510(k) (Traditional)
- Applicant: Sdi, Ltd.
- Decided: Jul 10, 2008 after 66 days
- Product code: OIV (Dental Amalgam)
- Device class: 2
- Regulation: 21 CFR 872.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K081273
Methodology: https://510kreport.com/methodology