# K021427: Clearfil SA Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Jun 7, 2002 after 35 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943165 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943166: Clearfil Liner Bond System, Kuraray Company, Ltd. (1994) Summary page 1.
- K012432: Modification to Clearfil Photo Bond, Kuraray Medical, Inc. (2001) Summary page 1.

## Indications for use
CLEAF'IL SA PRIMER is indicated for the following applications: 1)A dentin and enamel bonding system for composite resin restoration

Source page: https://510kreport.com/device/K021427
Methodology: https://510kreport.com/methodology