# K012441: Panavia F

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 6, 2001 after 37 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: 1 generation back to K002322 (2000). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002322: Modification to Panavia F, Kuraray America, Inc. (2000) Summary page 1.

## Most influential descendants
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K070956: SEA2 Self Etch Adhesive (2007), 0 descendants of its own

## Indications for use
PANAVIA F is indicated for the following applications: 1) Cementation of metal crowns and bridges, inlays and onlays. 2) Cementation of porcelain crowns, inlays, onlays and veneers. 3) Cementation of composite resin crowns, inlays and onlays 4) Cementation of adhesion bridges and splints 5) Cementation of metal cores and prefabrication posts 6) Bonded amalgam restorations

Source page: https://510kreport.com/device/K012441
Methodology: https://510kreport.com/methodology