# K062065: Riva Luting Plus

- Pathway: 510(k) (Traditional)
- Applicant: Southern Dental Industries, Inc.
- Decided: Nov 15, 2006 after 118 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.
96 later devices descend from it; 1 cites it directly.
0 of 97 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
- K071945: S4 Spinal System (2007), 95 descendants of its own
- K090657: Modification to: S4 Spinal System (2009), 94 descendants of its own
- K100623: Aesculap Implant Systems S4 Spinal System (2010), 92 descendants of its own
- K112551: S4 Spinal System (2011), 61 descendants of its own
- K123352: S4 Spinal System (2012), 51 descendants of its own

## Indications for use
Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns. Cementation of stainless steel crowns. Cementation of posts and screws. Attachment of metal orthodontic bands. Base or liner.

Source page: https://510kreport.com/device/K062065
Methodology: https://510kreport.com/methodology