# K214118: Riva Cem Automix

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Limited
- Decided: Aug 30, 2022 after 243 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
Longest line of descent: 3 generations back to K933139 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111185: Relyx Luting Plus Automix, 3M Espe Dental Products (2011) Summary page 4.
- K182854: GC FujiCEM 2 (Improved), GC America, Inc. (2019) Summary page 4.

## Indications for use
Permanent cementation of: 1) Porcelain fused to metal (PFM) to crowns and bridges 2) Prefabricated/cast posts 3) Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts 4) Ceramics (high strength)* to crowns & bridges, inlays & onlays *E.g. Zirconia, Lithium Disilicate, 5) Ceramics (low strength)* to inlays *E.g. Feldspathic porcelains, Glass ceramics

Source page: https://510kreport.com/device/K214118
Methodology: https://510kreport.com/methodology