The following data is part of a premarket notification filed by Dentsply Interntional with the FDA for X-smart Easy.
| Device ID | K092614 |
| 510k Number | K092614 |
| Device Name: | X-SMART EASY |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17404 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2009-12-02 |
| Summary: | summary |