RODO MEDICAL, INC. 30010NBA321 Smileloc® BY RODO

Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, inaccordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. Thedevice is a software and hardware system which includes Computer, dedicated display andcontrols. The SafeCT-29 is interfaced to CT scanners that are not equipped with the DoseCheck function. The device is connected to the CT Console video output via a standard videoconnector. The SafeCT-29 Computer’s internal video splitter captures the CT Console displayvideo, in real time, without affecting neither the CT console itself nor its display. This analogvideo signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital inputvideo using OCR software continuously. The radiation dose information as calculated by thescanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CTconsole itself nor its display and workflow. As specified by NEMA XR-25 Standard, thesafeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index isabove the predefined values set by the operating group, practice, or organization. SafeCT-29prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator,in accordance with NEMA XR-29*.The device records the details of such events, includingthe operator details and decisions. This record is available to the user.

1. DescriptioneCligner® is thin, transparent and removable orthodontic aligner. 2. Explanation 2.1 eCligner®, developed by 3D digital technology eCligner® is clear aligner made by 3D digital CAD/CAM system. Self-developed 3D simulation program is yearly upgraded with latest technology. All that’s needed to make whole set of eCligner® for patient is only one stone model. 2.2 eCligner® provides aesthetic and comfortable orthodontic treatment. Transparent aligner won’t be noticed by others and can temporarily be removed at one’s convenience. Recommended aligner wear time is 17 hours daily for the best treatment result. 2.3 eCligner® system process eCligner® has combined dental orthodontic concept and principles into 3D simulation system. Orthodontic professionals produce aligners based on such system, calibrating teeth movement and influences that affect teeth and even tissues. 1) eCligner® aligners consists of 3 aligners per step. (Patient should wear Soft,Medium,Hard aligners for a week each) 2) Patient should wear each aligners 17~19 hours daily. 3) Aligner enables gradual teeth movement per each step. 4) Advise patient to visit your clinic and check treatment progress every 3 weeks

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.

NB-TMP:The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Burr, Oval, 10 flute, 3.0mm

Oi Organic Cotton Tampons with Cardboard Applicator, Regular 16s

Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. This Rely A Bond Kit Contains: 14g Adhesive Paste ( push syringes), 16g Primer NonFluoride, 9 gm etchant liquid, mixing pad, spatulas and brushes. This is a Non-Fluoride Kit.

ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments.

Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, inaccordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. Thedevice is a software and hardware system which includes Computer, dedicated display andcontrols. The SafeCT-29 is interfaced to CT scanners that are not equipped with the DoseCheck function. The device is connected to the CT Console video output via a standard videoconnector. The SafeCT-29 Computer’s internal video splitter captures the CT Console displayvideo, in real time, without affecting neither the CT console itself nor its display. This analogvideo signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital inputvideo using OCR software continuously. The radiation dose information as calculated by thescanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CTconsole itself nor its display and workflow. As specified by NEMA XR-25 Standard, thesafeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index isabove the predefined values set by the operating group, practice, or organization. SafeCT-29prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator,in accordance with NEMA XR-29*.The device records the details of such events, includingthe operator details and decisions. This record is available to the user.

1. DescriptioneCligner® is thin, transparent and removable orthodontic aligner. 2. Explanation 2.1 eCligner®, developed by 3D digital technology eCligner® is clear aligner made by 3D digital CAD/CAM system. Self-developed 3D simulation program is yearly upgraded with latest technology. All that’s needed to make whole set of eCligner® for patient is only one stone model. 2.2 eCligner® provides aesthetic and comfortable orthodontic treatment. Transparent aligner won’t be noticed by others and can temporarily be removed at one’s convenience. Recommended aligner wear time is 17 hours daily for the best treatment result. 2.3 eCligner® system process eCligner® has combined dental orthodontic concept and principles into 3D simulation system. Orthodontic professionals produce aligners based on such system, calibrating teeth movement and influences that affect teeth and even tissues. 1) eCligner® aligners consists of 3 aligners per step. (Patient should wear Soft,Medium,Hard aligners for a week each) 2) Patient should wear each aligners 17~19 hours daily. 3) Aligner enables gradual teeth movement per each step. 4) Advise patient to visit your clinic and check treatment progress every 3 weeks

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.

NB-TMP:The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.