Submission Details
| 510(k) Number | K100833 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 24, 2010 |
| Decision Date | June 03, 2010 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
SYLE SMARTIP
Jun 2010
Decision
71d
Days
Class 1
Risk
About This 510(k) Submission
K100833 is an FDA 510(k) clearance for the SYLE SMARTIP, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Osspray, Ltd. (Gainesville, US). The FDA issued a Cleared decision on June 3, 2010, 71 days after receiving the submission on March 24, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.
Device Classification
| Product Code | EFB — Handpiece, Air-powered, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4200 |
Manufacturer
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