# K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Aug 21, 2015 after 156 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). 76 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 4.
- 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.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 4.
- K062410: Clearfil Esthetic Cement & DC Bond, Kuraray Medical, Inc. (2006) Summary page 4.
- K042929: Estenia C&B, Kuraray Medical Kurashiki Plant (2004) Summary page 4.
- K033938: Clearfil Protect Bond, Kuraray Medical, Inc. (2004) Summary page 5.

## Most influential descendants
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own
- K191524: Visalys Tooth Primer (2019), 0 descendants of its own

## Indications for use
[1] Cementation of crowns, bridges, inlays and onlays [2] Cementation of veneers [3] Cementation of adhesion bridges and splints [4] Cementation of prosthetic restorations on implant abutments and frames [5] Cementation of posts and cores [6] Amalgam bonding

Source page: https://510kreport.com/device/K150704
Methodology: https://510kreport.com/methodology