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 |