The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Clearfil Cr Inlay.
| Device ID | K890123 |
| 510k Number | K890123 |
| Device Name: | CLEARFIL CR INLAY |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY CO. 200 PARK AVE. New York, NY 10166 |
| Contact | Shuji Kawai |
| Correspondent | Shuji Kawai KURARAY CO. 200 PARK AVE. New York, NY 10166 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-11 |
| Decision Date | 1989-03-31 |