# K983361: Panavia F

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Nov 13, 1998 after 50 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 K933030 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933030: Panavia 21, Kuraray Co. (1994) Summary page 1.
- K971372: Variolink II, Ivoclar North America, Inc. (1997) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.

## 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 and onlays. 3) Cementation of to 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/K983361
Methodology: https://510kreport.com/methodology