The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Panavia Ex, A Dental Adhesive.
| Device ID | K855211 |
| 510k Number | K855211 |
| Device Name: | PANAVIA EX, A DENTAL ADHESIVE |
| Classification | Cement, Dental |
| Applicant | KURARAY CO. 875 AVENUE OF THE AMERICAS New York, NY 10001 |
| Contact | Paul Roberts |
| Correspondent | Paul Roberts KURARAY CO. 875 AVENUE OF THE AMERICAS New York, NY 10001 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-03-13 |