The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Statmatic 31 Handpiece Maintenance Unit.
| Device ID | K073319 |
| 510k Number | K073319 |
| Device Name: | STATMATIC 31 HANDPIECE MAINTENANCE UNIT |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Brenda Murphy |
| Correspondent | Brenda Murphy SCICAN LTD. 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 | 2007-11-26 |
| Decision Date | 2008-02-04 |