The following data is part of a premarket notification filed by Kuraray Company, Ltd. with the FDA for Clearfil St Opaquer.
| Device ID | K001913 |
| 510k Number | K001913 |
| Device Name: | CLEARFIL ST OPAQUER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Koichi K Ikuchi |
| Correspondent | Koichi K Ikuchi KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-23 |
| Decision Date | 2000-08-04 |