The following data is part of a premarket notification filed by Scican with the FDA for K-spray, Model 085-2715.
| Device ID | K062418 |
| 510k Number | K062418 |
| Device Name: | K-SPRAY, MODEL 085-2715 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Brenda Murphy |
| Correspondent | Brenda Murphy SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-18 |
| Decision Date | 2006-10-19 |