The following data is part of a premarket notification filed by Kuraray Company, Ltd. with the FDA for Clearfil Liner Bond System.
| Device ID | K943166 |
| 510k Number | K943166 |
| Device Name: | CLEARFIL LINER BOND SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Kyoichiro Shibatani |
| Correspondent | Kyoichiro Shibatani KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1994-08-10 |