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The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle, such as The Vigor C Low Speed Contra-Angle handpieces, and straight handpiece, such as The Vigor S Low Speed Straight handpieces. The motor contains chip air and water that help with removing debris from teeth cutting. The Low Speed Contra Angle Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. The Straight Handpiece contains chip air and water that help with removing debris from teeth cutting.

The Vigor Series Low speed dental handpieces & Accessories are similar to other low-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are powered by either low speed air motor or electric micro-motor that are reusable and ergonomically shaped, and are provided without a fiber optic light system.

The Vigor C Low Speed Contra-Angle handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of these contra angle handpieces allows easy "snap-on" connection and removal from the motor. The contra-angle handpieces contain both chip air and water that help with removing debris from teeth cutting.

The Vigor S Low Speed Straight handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of the Low Speed Straight handpiece allows easy connection and removal from the motor. It can be used with a variety of different burrs that conform to the specifications stated in ISO 1797-1. These nose-cones contain both chip air and water that help with removing debris from teeth cutting.

The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle and straight handpiece that are manufactured in accordance with ISO 7785-2. The locking mechanism of the motor allows easy connection and removal of any add-ons. The motor contains chip air and water that help with removing debris from teeth cutting.

The devices are reused and can be sterilized by the steam autoclave method.

This document is a 510(k) summary for the Thunder Tiger Corp. Vigor Series Low Speed Dental Handpieces & Accessories. It does not describe an AI medical device or a study involving AI. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these concepts are not applicable to the provided text.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design, function, and intended use, and adherence to relevant ISO standards, for non-AI medical devices.

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