Home / 510(k) Clearances / K103653

510(k) K103653

E3 TORQUE CONTROL MOTOR by Dentsply International, Inc. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2011
Date Received
December 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Dentsply International, Inc.

  • K160207 — ATLANTIS ISUS Implant Suprastructures (September 21, 2016)
  • K160232 — Disposable Barrier Sleeves and Covers (June 7, 2016)
  • K151439 — ATLANTIS ISUS (February 19, 2016)
  • K152247 — ATLANTIS Crown (January 29, 2016)
  • K151039 — ATLANTIS Abutment for NobelActive 3.0 (January 14, 2016)
  • K151619 — Prime&Bond Elect Universal Dental Adhesive (October 30, 2015)
  • K150535 — Cavitron Touch Ultrasonic Scaling System (June 16, 2015)
  • K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY (February 26, 2015)
  • K131907 — RAYPEX 6 (January 31, 2014)
  • K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (January 22, 2014)

Other clearances for product code EBW

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K251701 — Star E900 Electric System (January 12, 2026)
  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)