# K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Mar 30, 2012 after 52 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: 10 generations back to K931812 (1993). 37 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081583: Clearfil SA Cement, Kuraray Medical, Inc. (2008) Summary page 1.
- K100756: MALTA, 3M Espe AG Dental Products (2010) Summary page 1.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- 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) (2015), 4 descendants of its own
- 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 (2015), 2 descendants of its own
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own
- K191524: Visalys Tooth Primer (2019), 0 descendants of its own
- K183537: PANAVIA SA Cement Universal (2019), 0 descendants of its own

## Indications for use
[1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

Source page: https://510kreport.com/device/K120379
Methodology: https://510kreport.com/methodology