# K142623: PANAVIA SA Cement Plus Handmix

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Feb 26, 2015 after 163 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: 11 generations back to K931812 (1993). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120378: Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix (Universal (A2), White) Panavia S, Kuraray Medical, Inc. (2012) Summary page 4.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 4.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 4.
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 4.
- K111982: Clearfil DC Core Plus, Kuraray America, Inc. (2011) Summary page 4.

## Indications for use
Cementation of crowns, bridges, inlays and onlays Cementation of prosthetic restorations on implant abutments and frames Cementation of adhesion bridges and splints Cementation of posts and cores Amalgam bonding

Source page: https://510kreport.com/device/K142623
Methodology: https://510kreport.com/methodology