# K012705: Clearfil Photo Core

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 11, 2001 after 28 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: 1 generation back to K882006 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882006: Clearfil Photo Core, Kuraray Co. (1988) Summary page 1.

## Most influential descendants
- K033970: Clearfil Photo Core PLT (2004), 0 descendants of its own

## Indications for use
CLEARFIL PHOTO CORE is indicated for the following applications: 1) Restoration where a light-curing composite for core build-up is required.

Source page: https://510kreport.com/device/K012705
Methodology: https://510kreport.com/methodology