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The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units. The CEFLA Dental Micromotors family presents two versions: 1) long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable for implant & endodontic procedures: 2) short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the short version is especially suitable for prosthetic & restorative procedures. Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques. Furthermore, both versions of micro-motors are intended to be connect with the following two parts: 1) CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronic board; 2) handpieces which transmit movement to their tips or other instrument, legally marketed in USA. The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece.

APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.

APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition. The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to: (1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084). Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features: 1 hyperion X9 pro myray CEFLA S.C. 2 NewTom GIANO HR NewTom CEFLA S.C. 3 X-RADIUS TRIO PLUS Castellini CEFLA S.C. Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS. Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generator and X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units. The CEFLA Dental Micromotors family presents two versions: 1) long version (long) with Led light, especially suitable for implant & endodontic procedures; 2) short version (short) with optional Led light, especially suitable for prosthetic & restorative procedures. Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques. Furthermore, both versions of micro-motors are intended to be connect with the following two parts: 1) CEFLA Dental Unit, legally marketed in USA, thought a cord for connection between micromotor and the dental unit system including electronic board; 2) handpieces which transmit movement to their tips or other instrument, legally marketed in USA.

The NewTom 7G is a computed tomography x-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relative joints and of lower extremities including hip, upper leg, lower leg, midfoot, forefoot, relative joints, for use in diagnostic support. The device accomplishes this task by reconstructing a 3D matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device is managed and used by doctors, dentists, radiologists and other legally qualified professionals.

NewTom 7G is a computed tomography X-ray system using the cone-beam technology manufactured by CEFLA S.C. The proposed device NewTom 7G is a further development of the predicate device NewTom 5G XL (K183448) manufactured by CEFLA S.C. Like the predicate device NewTom 5G XL the proposed device NewTom 7G is equipped with X-ray tube generator and X-ray sensor (solid state X-ray imaging detector) for radiological images acquisition. The proposed device permits to acquire radiological images at varying radiographic angles by rotating around the patient. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible. This is achieved by collimating the X-ray beam. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to aid the patient positioning. The patient stay lie down on the patient support for a good stabilization. Control panel allow user actions as: patient support adjustment, selection of examination, selection of exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer. The software used to manage the images is NNT, a radiological imaging software developed by CEFLA S.C.

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to: (1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric andiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features: Like the predicate device hyperion X9 pro (K190496) the proposed device is equipped with X-ray tube generator and X-ray sensors (solid state X-ray imaging detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient, stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, intended to: 1. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity: 2. produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH); 3. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The proposed device is a panoramic (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system, that acquires radiological images by rotating around the patient. The rotating arm is attached to a support column capable of moving vertically through a motorized movement. The system is equipped with X-ray tube generator and detectors (sensors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device can be sold under three different product name and brands names for commercial needs, without changing any of the safety, electrical and functional features. The variants are: 1 hyperion X5 myray CEFLA S.C. 2 NewTom GO NewTom CEFLA S.C. 3 X-RADIUS COMPACT Castellini CEFLA S.C. Wherever the proposed device is mentioned, it is intended the device with its three different trade/ device names: hyperion X5, NewTom GO and X-RADiUS COMPACT.

hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to: (1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH): (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option.

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The NewTom 5G XL is cone beam computed tomography x-ray imaging system that acquires sequences of images of the head, including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandbular joint (TMI), other areas of the human skull and neck with sections of upper cervical spine and lower extremities for use in diagnostic support.

The NewTom 5G XL is a volumetric Cone Beam Computed Tomography (CBCT) system intended for diagnostic use. It obtains geometrical and x-ray information through digital 2D and 3D images of the objects in the area being examined. The NewTom 5G XL is able to analyze the regions of the head, including the dental and maxillofacial and the otorhinolaryngology areas, the cervical spinal column and upper and lower limbs. Particularly, the NewTom 5G XL can be used in the following fields: - maxillofacial surgery, orthodontics, implants, endodontics, otorhinolaryngology, prosthetics, and orthopedics. The NewTom 5G XL CBCT device acquires a sequence of x-ray images by performing a rotation around the patient's head then, starting from these images, reconstructs a 3D matrix of the examined volume and produces 2D views of it. From these views it is possible to reconstruct other 2D images on which 3D images, angle and distance measurements can be taken. Each image can be printed and/or stored in a magnetic/optical media (CD, hard disk, network, USB pen or other mass storage device). NewTom 5G XL consists of three main components: the scanner unit, the motorized patient support and the main workstation (secondary workstations could be also available as optional) that supports the dedicated software, enabling data acquisition. The software requires a Microsoft Windows OS (version 7 or later).

B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

The Family of steam sterilizers B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection. The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.