# K061906: Clearfil Ceramic Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 28, 2006 after 85 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931812 (1993). 21 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012730: Clearfil Porcelain Bond Activator, Kuraray Medical, Inc. (2001) Summary page 1.
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001) Summary page 1.
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 1.
- K905220: Monobond S, Ivoclar North America, Inc. (1990) Summary page 1.

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond (2013), 1 descendant of its own
- K091705: Primer Plus (2009), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own

## Indications for use
1) Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin 2) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

Source page: https://510kreport.com/device/K061906
Methodology: https://510kreport.com/methodology