# K030516: Riva-Self Cure

- Pathway: 510(k) (Traditional)
- Applicant: Southern Dental Industries, Inc.
- Decided: Apr 17, 2003 after 57 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K201937: Ceramir Restore QuikCap (2020), 0 descendants of its own

## Indications for use
Suitable for use in non-load bearing Class I and II restorations, Class V restorations, paediatric and geriatric applications, core build-ups, root surface restorations and semi-permanent fillings. Also suitable for use as a base material for Class I and II cavities using the sandwich technique with composite restorations.

Source page: https://510kreport.com/device/K030516
Methodology: https://510kreport.com/methodology