# K012729: Clearfil Repair

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 13, 2001 after 30 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: 1 generation back to K001914 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001914: Clearfil Repair, Kuraray Company, Ltd. (2000) Summary page 1.

## Indications for use
CLEARFIL REPAIR is indicated for the following applications: 1. Intraoral repairs of fractured porcelain or composite facing crowns/bridges. 2. Intraoral repairs of fractured all ceramics restorations. 3. Intraoral repairs of fractured porcelain and composite inlays/onlays.

Source page: https://510kreport.com/device/K012729
Methodology: https://510kreport.com/methodology