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For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage. Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243.

This device represents the combination into one device of two previously cleared devices, the Diagnodent Laser Fluorescence Caries Detection Device with the KEY Laser III 1243.

Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system.

The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.

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

For use as an aid in the diagnosis of dental caries.

This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.

The KaVo K*E*Y Laser Models 1243+ and 1242 are intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectorny in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery, flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement) Tooth preparation to obtain access to the root canal Pulpotomy Pulp Extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning. The KaVo K*E*Y Laser Models 1243+ and 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include: Removal of carious tissue Enamel Etching Cavity preparation Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curretage.

The KaVo KEY Laser 1243+ is an erbium laser which emits its energy at 2.94 microns. The laser consists of a cabinet, foot switch, fiber optic and hand pieces, and a software controlled user/laser interface.

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 In eXam Intraoral X-ray device is to be used exclusively within dentistry as an extraoral source of x-rays.

The KaVo In eXam Intraoral Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area. The KaVo In eXam Intraoral Dental X-Ray System is comprised of the following main components: X-ray tube head, Yoke with user interface capabilities, Articulated arm, Horizontal arm, Electronic control unit, Wall mount, Cone. The power supply is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 7mA. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of expsure time is 0.012 through 1.88 seconds.

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