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For use as an aid in the detection and localization of subgingival dental calculus.

This submission is for a modification of a device system cleared under K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface. Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood.

For acquiring, viewing, handling, and storage of dental color images and radiographs.

KaVo ERGOcom®/ERGOcam® system consists of four main components: - The ERGOcom® Video control box. - One of two versions of the ERGOcam® Cameras: The ERGOcam® 3 of the ERGOcam® 4 camera. - A video display, flat panel color from 15 to 19" with touch screen control. - A PC compatible computer with the KaVo Device Interface System Software installed. The Device Interface System has the following components: - 1. CCCDIS. The CCCDIS software is used to administer and configure the software components in the KaVo Device Interface System. The CCCDIS acts as the interface of the KaVo Device Interface System with third party applications - ERGOcam Control The ERGOcam Control software is used to configure individual parameters of the ERGOcam 4 - ERGOcom Control The ERGOcom Control software is used for the PC-assisted status display, configuration and service support of the ERGOcom 3. - ERGOvideo Control The ERGOvideo Control software is used for generating and displaying video imaging data created with ERGOcom 2 / ERGOcom 3 andERGOcam 3 / ERGOcam 4 - ERGOcam Viewer The ERGOcam Viewer is used for demonstrating the use of the ERGOvideo Control, ERGOcam Control and ERGOcom Control. The ERGOcam Viewer is used to store and administer imaging data that have been generated with the software components referred to above. - VirtualCom2 VirtualCom2 is used to convert the foot starter and camera cradle signals from ERGOcom 3 to a format that is compatible with ERGOcom 2. These signals are only used to control program modules within a practice management software that allows the recording of images with a KaVo intraoral camera, thereby meeting the interface specification for the serial interface of ERGOcom 2 The intraoral camera emits video signals which generate an image of the area under inspection (the patient's oral cavity for instance) on a screen or other visual display medium. The generated image is used for the patient's information and to support the diagnosis.

The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.

This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream. The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.

The KaVo Everest® ZH-Blank is used in the manufacture of dental prosthetics.

The KaVo Everest® ZH-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics