# K183537: PANAVIA SA Cement Universal

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Apr 25, 2019 after 127 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: 12 generations back to K931812 (1993). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS), Kuraray Noritake Dental, Inc. (2015) Summary page 4.

## Indications for use
PANAVIA SA Cement Universal is indicated for the following uses: [1] Cementation of crowns, bridges, inlays and onlays [2] Cementation of prosthetic restorations on implant abutments and frames [3] Cementation of adhesion bridges and splints [4] Cementation of posts and cores [5] Amalgam bonding

Source page: https://510kreport.com/device/K183537
Methodology: https://510kreport.com/methodology