The following data is part of a premarket notification filed by Osspray Ltd with the FDA for Syle Smartip.
| Device ID | K100833 |
| 510k Number | K100833 |
| Device Name: | SYLE SMARTIP |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | OSSPRAY LTD 3116 N.W. 62ND TERRACE Gainesville, FL 32606 |
| Contact | David Greenspan |
| Correspondent | David Greenspan OSSPRAY LTD 3116 N.W. 62ND TERRACE Gainesville, FL 32606 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-24 |
| Decision Date | 2010-06-03 |
| Summary: | summary |