The following data is part of a premarket notification filed by Dentsply International Inc. with the FDA for E3 Torque Control Motor.
| Device ID | K103653 |
| 510k Number | K103653 |
| Device Name: | E3 TORQUE CONTROL MOTOR |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-05-26 |
| Summary: | summary |