# K081583: Clearfil SA Cement

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Jul 28, 2008 after 53 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: 9 generations back to K931812 (1993). 24 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 34 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 1.
- K062410: Clearfil Esthetic Cement & DC Bond, Kuraray Medical, Inc. (2006) Summary page 1.
- K041474: Maxcem, Sybron Dental Specialties, Inc. (2004) Summary page 1.

## Most influential descendants
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S (2012), 5 descendants of its own
- 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
- K120378: Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix (Universal (A2), White) Panavia S (2012), 1 descendant of its own

## Indications for use
1) Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal 2) Cementation of metal cores, resin cores, metal posts or glass-fiber posts

Source page: https://510kreport.com/device/K081583
Methodology: https://510kreport.com/methodology