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The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, secondary caries, and tooth cracks. The DEXIS Cari Vu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry.

The device is used as an intraoral camera to acquire images in the oral cavity of the patient. The camera combines three different known applications from available intraoral cameras in one device. These applications are standard camera functionality, transillumination and fluorescence caries detection. Therefore, the camera uses different light colors for each of the three applications to illuminate the tooth. In combination with an optical system, CMOS sensor, and an internal image processing unit, a digital image of the tooth is generated. The live images are transferred as a standard mjpg video stream via USB interface to a running computer and can interface with a dental imaging software such as for example CONEXIO for basic intraoral camera management functionality. The device may be used as an aid for monitoring caries lesion size and shape by comparing images taken with the Dexis CariVu 3-in-1 by KaVo over time, by using different reference points, such as tooth contour and position the device to optimize capturing tooth features previously recorded in a still or video image. For easy use the camera is equipped with an autofocus mechanism which will provide a sharp representation of the tooth which is placed in the center of the imaqe. The autofocus provides the ability to have sharp images from close distances of about 2mm to about 120mm distance. The different operation modes are described as follows: 1.) Color mode: For normal color images, a white LED for illumination is used. With this light the camera provides coloured images or videos. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. 2. Fluorescence mode: For the fluorescence mode the blue LED illumination is used. The blue light excites bacterial porphorines as an aid to detect caries. To enhance the image quality and to minimize external light influence on the fluorescence effect the accessories Fluorescence Cover Vision Full HD can be used optionally with the camera. The Fluorescence Cover Vision Full HD is a rubber cap which can be slipped on the front camera head and prevent or minimize external light on the images surface of the tooth. After each usaqe the Fluorescence Cover Vision Full HD will be reprocessed separately. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. This mode is used to record images and videos to aid in the diagnosis of caries (mainly in the occlusal area) and plaque by means of fluorescent effect. 3. Transillumination mode (by the use of near infrared light): The transillumination mode provides images to aid in the detection of caries. For this mode near infrared light will be used. The near infrared light penetrates the side of the tooth near gingiva and illuminates the enamel of the tooth to produce gray scale images whereby intact enamel appears bright, and defects such as caries or cracks result in diffusion of light path and create an area of dark appearance. To use this mode, the Tip Vision Full HD must be attached to the device as the LEDs for the illumination are located inside the Tip Vision Full HD. The Tip Vision Full HD touches the side of the tooth and gingiva and illuminates it from two sides whereas the image is taken from the top. The DEXIS CariVu 3-in-1 by KaVo is available in two similar models. The differences between the models are a wall mounted version to store the device with a cable length of 2.5 meters (model 1.011.4444) and a table holder version to store the device on a dental unit with a cable length of 1.55 meters (model 1.013.1700). All critical components within the DEXIS CariVu 3in-1 by KaVo are common. A disposable sheath is used with the device to mitigate the potential for cross contamination.

The PROPHYflex 4 Handpiece and Accessories is a dental handpiece intended for perform supragingival and subgingival prophylaxis treatments. The prophylaxis treatments are obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the treatment site. PROPHYflex 4 Handpiece and Accessories in supra-gingival configuration is intended for use in the cleaning and polishing of teeth by removal soft deposits and areas of discoloration as well as preparing teeth for fillings or veneers and cleaning fixed bands and brackets on orthodontic appliances. PROPHYflex 4 Handpiece and Accessories in subgingival configuration is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The PROPHYflex 4 is an air polishing device/powder jet handpiece that projects a mixture of water and air with sodium bicarbonate, calcium carbonate or fine glycine power onto tooth surfaces. The device includes the handpiece main body with adjustable spray feature, two cannulas, a wrench for installing the cannula, two interchangeable gripping sleeves, powder container with cover, a cleaning burr and nozzle pin, and a set of spare o-rings. An optional adapter and perio tip can be installed for subgingival treatments. The powder is filled into the powder container by the user. When activated through foot control, air is pushed into the powder container, swirling the powder and pushing it through the device and out of the cannula. The spray is only mixed with the air and powder at the very tip of the cannula, providing an even and gentle cleaning effect. The amount of powder can be regulated via three different spray settings by the adjusting ring, helping the users to perform individual treatments such as subgingival biofilm removal, removal of discoloration and bacterial plaque, orthodontics, cleaning prior to fissure sealing, prosthetics, conservative and aesthetic dentistry by providing the possibility to adjust the cleaning effects to the clinical situation of the patient at hand. The components of the PROPHYflex 4, including the powder container, is to be completely reprocessed after each use. The three powder levels are as follows: - Highest Level: Suitable for supragingival treatment and offers full cleaning power . - Medium Level: Suitable for sub- and supragingival treatment and enables . gentle cleaning at a reduced powder quantity - . Lowest Level: Helps rinsing the powder off the tooth and blowing the powder from the system after the treatment During supraqinqival treatments (e.g. stain removal), the device doesn't touch the patient but will be placed 3 – 5 mm from the area that is to be cleaned. During subgingival treatments (biofilm management) with the perio tip, the tip is inserted into the pocket up to 5mm and angled towards the tooth.

The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).

The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to drive the COMFORT drive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry

The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord.

The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.

The ESTETICA Dental Treatment Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light and a monitor. Various handpieces and accessories can be added to the ESTETICA Dental Treatment Unit and Accessories. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes and SE and HVE vacuum instruments.

The MASTERmatic LUX handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The MASTERmatic LUX electrical-driven handpieces - MASTERmatic LUX M25 L, MASTERmatic LUX M20 L, MASTERmatic LUX M10 L, MASTERmatic LUX M07 L, MASTERmatic LUX M29 L, MASTERmatic LUX M05 L are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the MASTERmatic LUX handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. Dental burs and other attachments according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) will be used with the MASTERmatic LUX handpieces.

EXPERTsurg: This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations). INTRA LUX S600 LED: The medical device is intended to drive / operate a dental handpiece / contra-angle handpiece equipped with a handpiece connection according to ISO 3964. This medical device is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2 and classified as a type B application part. SURGmatic S201 L / C; SURGmatic S201 XL / XC; SURGmatic S11 L / C: The medical device is intended for the following uses: Surgery such as setting an implant, bone augmentation, sinus lift, tooth extraction procedures, implantology, osteotomia, root resection and oral, jaw and facial surgery.

The MASTERsurg / EXPERTsurg is a dental surgical system out of: - EXPERTsurg (surgical control unit) - INTRA LUX S600 LED (surgical motor) - SURGmatic S201 L / C (handpieces) - SURGmatic S201 XL / XC (handpieces) - SURGmatic S11 L / C (handpieces) The MASTERsurg / EXPERTsurg is a system out of a surgical control unit (EXPERTsurg), a surgical motor (INTRA LUX S600 LED) and different handpieces (SURGmatic). The surgical control unit (EXPERTsurg) consists of a surgical controller, a motor cable, an instruments tray, a holder and a tube set. The surgical motor (INTRA LUX S600 LED) consists of the motor, a stopper for maintenance purposes and exchange O-rings for the motor coupling. As a functional principle the software-based surgical controls the speed and torque of a dental micro motor. The unit is equipped with a pump for the use with external irrigation tubing allowing irrigation of the working area. The surgical control unit is operated through the buttons on the tabletop console or via foot control. The surgical control unit is intended to be used with the INTRA LUX S600 LED motor. Straight or contra-angle handpieces with a handpiece connection according to ISO 3964 can be equipped. The instrument tray allows the dentist to deposit the SURGmatic handpieces in a safe position. The holder is intended to be used for general storage. The tube set is needed to deliver the external irrigation from the bottle (not part of this 510(k)) to the SURGmatic handpieces. A power cord provides electric power to the unit. The EXPERTsurg will be delivered with software on the surgical control unit. The EXPERTsurg follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings. Each of the different handpieces (SURGmatic) consists of the handpiece, a spray clip (only SURGmatic S201 L / C and SURGmatic S201 XL / XC), a jet needle for cleaning purposes and a tube for the external spray. The SURGmatic handpieces are electrical driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system (L version). The devices can be sterilized by the steam autoclave method. Through the INTRA LUX S600 LED motor connected to the surgical control unit, the SURGmatic handpieces equipped with a handpiece connection according to ISO 3964 receives the energy, the cooling water and air for treatment and the light for illumination the operation area (L version). Surgical burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797 can be used with the SURGmatic handpieces. The SURGmatic handpieces use external spray allowing external irrigation to the working area. The mechanism of action for the SURGmatic handpieces is as follows. The dental straight and contra-angle handpieces are electrical-driven handpieces which will be supplied with energy, air and light through the dental micro motor of the surgical control unit. Dental burs (not part of this 510(k)) according to ISO 1797 could be inserted into the chuck system of the handpieces. Based on the speed adjusted in the surgical control unit the handpiece bur rotates up to 40,000 rpm. The SURGmatic handpieces interacts with the patient through a rotating bur with the patient teeth according to the intended use.

The MASTERtorque LUX 8900 L is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The MASTERtorque LUX 8900 L air-driven handpieces are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the MULTIflex coupling connected to a dental unit, the MASTERtorque LUX 8900 L receives the air for high speed turbine, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. The MASTERtorque LUX 8900 L is equipped with the Direct Stop Technology which reduces the stopping time of the high speed turbine and so of the bur. The back suction also will be reduced due to the Direct Stop Technology. Additionally the MASTERtorque LUX 8900 L will be supplied with an exchange filter for the water lines inside of the dental air-driven handpiece. The exchange filter filters the spray water inside the product. The filter is considered to be a spare part. If there is an insufficient amount of cooling water out of the MASTERtorque LUX 8900 L according to the instructions.for use, this spare has to be exchanged. Further one there is a jet needle supplied with the MASTERtorque LUX 8900 L. By using this part the operator is able to clean the spray holes in the head of the product if there is an insufficient amount of cooling water out of the MASTERtorque LUX 8900 L according to the instructions for use.

The DIAGNOcam 2170 Is a diagnostic ald for the detection of open or includent carles lesions above the gingiva and for monitoring the progress of such lesions. Indications: - Detection of smooth surface caries - Detection of occlusal carries - Detection of proximal carles - Detection of Initial caries - Detection of secondary caries - Detection of cracks

The DIAGNOcam 2170 is a handheld laser fluorescence caries detection device which uses the DIFOTI technology (Digital Imaging Fiberoptic Transillumination) as the functional principle. KaVo DIAGNOcam 2170 delivers images, which are reminiscent of X-rays but which are completely radiation free - by means of a light that is especially adapted to this examination method. The tooth structures allow the passage of light from the entry site to the camera. Areas that block light transmission (e.g. carious lesions) show up clearly as well delimited, dark areas. A digital camera captures the actual situation and makes it visible in real-time on the screen. The USB connector provides electric power to the unit. The DIAGNOcam 2170 will be delivered with a firmware (unit) at the handheld device which is responsible for steering of the camera functions and a computer based software (image) which is responsible to show / display the pictures, store / save the pictures and the possibility of a life stream. The internal laser diode generates an exact wavelength being detectable by the CCD sensor. The DIAGNOcam 2170 follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings. The DIAGNOcam 2170 works with a laser wavelength at 788 nm and an output power of 2mW for each laser diode (2 sources). The maximum output power is 21mW/cm2.

The ELECTROtorque TLC 4893 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the INTRAmatic KL 702 motor for operation of electricallydriven dental handpieces. These devices are designed for use by a trained professional in the field of general dentistry.

The ELECTROtorque TLC 4893 dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close a treatment unit at the location preferred by the dentist. The ELECTROtorque TLC 4893 system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The ELECTROtorque TLC 4893 dental control unit is a software-driven device. The software controls the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, (6) Monitoring power consumption, and (7) SAFEdrive. The new SAFEdrive software feature monitors the power consumption of electrical hand pieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient. The user can navigate through the software menu via the control panel (see Figure 2.0). The INTRAmatic KL 702 motor is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2. The motor connects onto the KaVo specific tubing of the dental treatment unit ELECTROtorque. The speed of the INTRAmatic KL 702 is controlled by air pressure of the dental treatment center. The converted pneumatic output signal (electrical energy) from a dental treatment center drives the motor to operate an electrically-driven dental handpiece. Electricallydriven dental handpiece, which conform to ISO 3964, can be attached on the motor. The INTRAmatic KL 702 is intended only for dental treatment by a dental professional.