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The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: - Transurethral resection of prostate (TURP) for benign prostatic hypertrophy - Transurethral incision of the prostate (TUIP) or bladder neck - Transurethral resection of bladder tumors (TURBT) - Cystodiathermy - Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS models only)

The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.

Wireless Smart Thermometer is intended to be used at home for the intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm. The devices are reusable for the adult and pediatic patient population (not suitable for neonates).

Wireless Smart Thermometer (Model: FDTH3400, FDTH3401, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) utilizes a modular design method and consists of six main modules: - Buzzer module: Control the product buzzer to produce audible notifications; - Display module: Display driver content through notifications, and combine to produce various display interfaces; - Battery voltage management module: Detect the battery power of the product and output the battery power level; - Temperature measurement module: After collecting the electrical signal of the external temperature sensor through AD, it is restored to the temperature value through various algorithms - Button module: This module is used to identify whether the product button is active; - Wireless function module: Transfer the measurement data to the mobile device.

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、 FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、 FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT) includes utilize modular design method. It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, , wireless function module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filter signal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and coagulation modes. The maximum output power is 500 W. The front panel GUI (graphical user interface) features soft keys and digital displays for: • the connection status of accessories connected to the electrosurgical generator. • the current settings of the chosen output mode (Cut/ Coag), and possibility to adjust it • Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for output activation) • Electrode shortcut Alarm reset At switch on, Serial Number and Software Version are displayed

The Heat StimPlus, Model FDES115 is intended TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities. EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

The Heat StimPlus(Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation. It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10. FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Stimulation from FDES115 is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics. The accessories include:Type-C cable,an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The FDES115 is considered - OTC devices.

FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.

FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.

FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations. StoneBite® is indicated for: - bite registrations - I key for intraoral registration StoneBite® scan is indicated for: - i bite registrations - key for intraoral registration - . optical collection of data in CAD/CAM/CIM systems

StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are vinyl polysiloxane based materials. StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.

Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

Varnish for final coating for resin temporaries to produce a smooth and shiny surface.

The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.