# K012438: Modification to Panavia 21

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 5, 2001 after 36 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
PANAVIA 21 is indicated for the following applications: 1) Cementation of adhesion bridges or splints 2) Cementation of metal crowns, bridges and inlays/onlays 3) Cementation of silanated porcelain and cured composite crowns or inlays/onlays 4) Cementation of preformed posts or cast post and cores 5) Bonded amalgam restoratios

Source page: https://510kreport.com/device/K012438
Methodology: https://510kreport.com/methodology