The following data is part of a premarket notification filed by Kuraray Company, Ltd. with the FDA for Clearfil Dc Cement.
| Device ID | K980232 |
| 510k Number | K980232 |
| Device Name: | CLEARFIL DC CEMENT |
| Classification | Cement, Dental |
| Applicant | KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Hiroyuki Yonekura |
| Correspondent | Hiroyuki Yonekura KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-22 |
| Decision Date | 1998-02-24 |