Alpha Endo Handpiece (Alpha Endo)

The Alpha Endo Handpiece is a cordless motor handpiece with torque control used to drive files in both reciprocating and rotation modes during root canal therapy preparation. It provides variable speed control and automatic torque limiting with an automatic protection mode to prevent file breakage.

The device uses a variable speed gear plate to convert high motor speed to low speed required for root canal preparation while obtaining larger cutting torque. Speed and maximum torque are selectable and always controlled by a torque sensor with automatic protection mode. It has the same intended use and similar technological characteristics as the predicate device.

Not stated in this summary.

Non-clinical tests verified that the Alpha Endo Handpiece met all design specifications similar to the predicate device (Endo Motor, product code EKX). All performance testing met acceptance criteria, establishing substantial equivalence to the legally marketed predicate device.