The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Panavia Sa Cement Plus Automix; (universal(a2), White, Translucent); Value Pack (universal(a2), Translucent); Automix Trial (universal(a2), White, Translucent); Mixing Tip; Endo Tip (ss).
| Device ID | K142625 |
| 510k Number | K142625 |
| Device Name: | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing Tip; Endo Tip (SS) |
| Classification | Cement, Dental |
| Applicant | KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL 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 | 2014-09-16 |
| Decision Date | 2015-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003392KA1 | K142625 | 000 |
| EKUR003383KA1 | K142625 | 000 |
| EKUR003384KA1 | K142625 | 000 |
| EKUR003385KA1 | K142625 | 000 |
| EKUR003387KA1 | K142625 | 000 |
| EKUR003388KA1 | K142625 | 000 |
| EKUR003389KA1 | K142625 | 000 |
| EKUR003390KA1 | K142625 | 000 |
| EKUR003391KA1 | K142625 | 000 |
| EKUR003382KA1 | K142625 | 000 |