The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Pana Spray Plus.
| Device ID | K163483 |
| 510k Number | K163483 |
| Device Name: | PANA SPRAY Plus |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKANISHI, INC. 700 Shimohinata Kanuma-shi, JP 322-8666 |
| Contact | Kimihiko Satoh |
| Correspondent | Diane Rutherford KEN BLOCK CONSULTING 1201 RICHARDSON DRIVE, SUITE 160 Richardson, TX 75080 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560224991080 | K163483 | 000 |
| 04560264538566 | K163483 | 000 |
| 04589551356454 | K163483 | 000 |
| 04589551356447 | K163483 | 000 |
| 04589551356430 | K163483 | 000 |
| 04589551392063 | K163483 | 000 |
| 04560264502970 | K163483 | 000 |
| 04560264502963 | K163483 | 000 |