The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Panavia F.
| Device ID | K983361 |
| 510k Number | K983361 |
| Device Name: | PANAVIA F |
| Classification | Cement, Dental |
| Applicant | KURARAY AMERICA, INC. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Koji Fujita |
| Correspondent | Koji Fujita KURARAY AMERICA, INC. 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 | 1998-09-24 |
| Decision Date | 1998-11-13 |
| Summary: | summary |