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The VarioSurg 4 is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of root canals.

VarioSurg 4 consists of the control unit, the foot control, the ultrasonic handpiece, and accessories. The control unit generates an ultrasonic electrical signal and is used to control functions such as power output, irrigation flow, and operation mode. The foot control allows for "hands-free" control of the irrigation flow, program selection, and turning the ultrasound on/off. The ultrasonic handpiece (VS4-LED-HPSC) incorporates a piezoelectric transducer that converts the electrical signal into mechanical vibrations and is also equipped with LED illumination.

VarioSurg 4 is intended for use in dental periodontal therapy and dental oral surgery for procedures such as bone cutting, root canal preparation, and the removal of deposits from teeth. The device is designed to be used with the ultrasonic handpiece, which drives various tips vibrating at an ultrasonic frequency to perform cutting, removal, and incision of hard and soft tissues within the oral cavity.

A feature of this product is its Bluetooth connectivity with the foot control and its ability to connect to the Surgic Pro2 (K233117) system. When connected, a single foot control can operate both systems. The product is supplied non-sterile. The handpiece and tips are to be cleaned and sterilized at a medical facility before use and are intended for repeated use.

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The VarioSurg device is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of root canals.

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This document is a 510(k) clearance letter from the FDA for the VarioSurg Bone Surgery System and Ultrasonic Scaler. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria or a specific study proving the device meets them.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts, qualifications of experts, or adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set or how ground truth for the training set was established.

This document confirms regulatory clearance based on substantial equivalence to a predicate device, which is a different type of evaluation than a clinical or performance study that would establish and demonstrate adherence to specific acceptance criteria.

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