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The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.

EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183. EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area. This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of device-specific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps. EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.

To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.

EVOCLEAN CLEANsert Ultrasonic Insert is used with EVOCLEAN Ultrasonic Scaler that was cleared under K201317. It is used by dental professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth. EVOCLEAN CLEANsert Ultrasonic Inserts are available in three models (ELITE IF-50 Universal Slim, PRO IF-50 Universal Slim and CLASSIC P-10 Universal). Each model has two oscillating frequencies (25KHz and 30KHz), three different grip sleeves and two water supply methods (internal/external). EVOCLEAN CLEANsert Ultrasonic Insert consists of a Tip, a Magnetostrictive stack, an Inner O-ring, a Grip sleeve and an Outer O-ring. CLASSIC P-10 Universal has an external water tube.

TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.

TTBIO EVOCLEAN Ultrasonic Scaler consists of an ultrasonic generator, a handpiece, a power supply, a foot pedal and other minor accessories. There are two models of TTBIO EVOCLEAN Ultrasonic Scaler, one is EVOCLEAN and the other is EVOCLEAN+. The specifications of these two models are almost the same; the major difference is the connection type, fix and plug in, between the handpiece and main unit. TTBIO EVOCLEAN Ultrasonic Scaler uses ultrasonic energy to generate mechanical micro-vibration of the available inserts to perform the dental procedures defined in its intended use. TTBIO EVOCLEAN Ultrasonic Scaler is a multi-frequency available device which is compatible with 25 KHz or 30 KHz inserts. The system will automatically detect the insert oscillation frequency, need not to operate it manually. The handpiece is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, search and locate the resonant frequency of the insert, which varies according to the insert in use.

The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.

The EVO 450 series High Speed Handpieces are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. Others could be connected to hose connectors type 2 or type 3 according to ISO 9168:2009 Dental handpieces-Hose connectors for air driven dental handpieces. The EVO 450 series High Speed Handpieces will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. For proper operation, make sure that the supply of cooling air is dry, clean and uncontaminated. Make sure that air is not emitted in the direction of the bur. After each patient use, disinfect the tubing waterlines including the handpiece waterlines by flushing with cleaning water to prevent cross-contamination according to handpiece waterlines disinfection procedure of main dental unit.

Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

Thor 700 Electric Handpiece System is composed of a system unit, which is connected to a : power supply and a control tube, that system unit drives a dental drive device. The system unit converts pneumatic output from the dental treatment unit to control the torque, speed and directional rotation of the dental drive device. The dental drive device, in turn, provides the control for motorized dental handpieces. The inputs to the system unit are supplied by a dental treatment unit. Inputs can also be controlled by the foot pedal of the treatment unit.