The following data is part of a premarket notification filed by Kuraray Noritake Dental, Inc. with the FDA for Panavia V5: Standard Kit (universal (a2)), Standard Kit (clear), Introductory Kit (universal (a2)), Introductory Kit (clear), Sample Pack (universal (a2)), Paste (universal (a2)), Paste (clear), Paste (brown (a4)), Paste (white), Paste (opaque), Try-.
| Device ID | K150704 |
| 510k Number | K150704 |
| Device Name: | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try- |
| Classification | Cement, Dental |
| Applicant | KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 1000004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 1000004 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-18 |
| Decision Date | 2015-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003635KA1 | K150704 | 000 |
| EKUR003601KA1 | K150704 | 000 |
| EKUR003602KA1 | K150704 | 000 |
| EKUR003604KA1 | K150704 | 000 |
| EKUR003605KA1 | K150704 | 000 |
| EKUR003608KA1 | K150704 | 000 |
| EKUR003611KA1 | K150704 | 000 |
| EKUR003612KA1 | K150704 | 000 |
| EKUR003613KA1 | K150704 | 000 |
| EKUR003614KA1 | K150704 | 000 |
| EKUR003615KA1 | K150704 | 000 |
| EKUR003621KA1 | K150704 | 000 |
| EKUR003622KA1 | K150704 | 000 |
| EKUR003623KA1 | K150704 | 000 |
| EKUR003624KA1 | K150704 | 000 |
| EKUR003625KA1 | K150704 | 000 |
| EKUR003626KA1 | K150704 | 000 |
| EKUR003629KA1 | K150704 | 000 |
| EKUR003630KA1 | K150704 | 000 |