The following data is part of a premarket notification filed by Nsk America Corp. with the FDA for Pana-spray.
| Device ID | K052700 |
| 510k Number | K052700 |
| Device Name: | PANA-SPRAY |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NSK AMERICA CORP. 700-B COOPER CT. Schaumburg, IL 60173 |
| Contact | Hirohiko Murase |
| Correspondent | Hirohiko Murase NSK AMERICA CORP. 700-B COOPER CT. Schaumburg, IL 60173 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-12-20 |