510(k) K092614
K092614 is an FDA 510(k) premarket notification submitted by Dentsply Interntional for the device "X-SMART EASY". The FDA issued a decision of Substantially Equivalent on December 2, 2009. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Dentsply Interntional has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2009
- Date Received
- August 26, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type