# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Jan 27, 2015 after 133 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: 11 generations back to K931812 (1993). 69 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S, Kuraray Medical, Inc. (2012) Summary page 4.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 4.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 4.
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 4.
- K111982: Clearfil DC Core Plus, Kuraray America, Inc. (2011) Summary page 4.

## Most influential descendants
- 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 [2] Cementation of prosthetic restorations on implant abutments and frames [3] Cementation of adhesion bridges and splints [4] Cementation of posts and cores [5] Amalgam bonding

Source page: https://510kreport.com/device/K142625
Methodology: https://510kreport.com/methodology