The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Panavia Sa Cement Automix Value Pack (universal (a2), White) Panavia Sa Cement Automix (universal (a2), White) Panavia S.
| Device ID | K120379 |
| 510k Number | K120379 |
| Device Name: | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S |
| Classification | Cement, Dental |
| Applicant | KURARAY MEDICAL INC. OTE CENTER BLDG. 7F, 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY MEDICAL INC. OTE CENTER BLDG. 7F, 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-07 |
| Decision Date | 2012-03-30 |
| Summary: | summary |