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SYNERGY is intended for use in: Augmentation or reconstructive treatment of alveolar ridge Filling periodontal defects Filling defects after root resection, apicoectomy, and cystectomy Filling extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Synergy is a Xenograft of bovine origin. It contains macro and micro porous structures similar to Bio-Oss. Synergy is a purified osteoconductive mineral structure produced from bone in a multi-stage purification process. Synergy is chemically as well as structurally comparable to mineralized Bio Oss and Equimatrix. Synergy is used as an adjunctive therapy in restoring bony defects in the mouth. Synergy is produced from selected bovine bone. Physical and chemical analysis has demonstrated that the composition of Synergy is similar to the predicate devices which have been shown to be anorganic, osteoconductive hydroxyapatite bone mineral. The product is milled to generate granules of two sizes (0.30 - 0. 84 mm or 0.84 - 2.0 mm) which are put into glass vials and sterilized by gamma irradiation. Synergy has porous structure and composition, encouraging the formation and ingrowth of new bone at the implantation. In the course of time Synergy is partially remodelled by osteoclasts and osteoblasts (physiological remodelling).

This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It may be used for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading. This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. These devices are intended for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edentualism such as: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants. Immediate loading temporary abutments for repairing failing tooth and implant supported restorations. Transitional supports for immediate replacement of missing teeth, For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.

This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant in various procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards. This device is an endosseous dental implant consisting of the major component, a root-form, screw type implant with a specialized head, and accessories, designed to facilitate placing and using the implant in orthodontic procedures.. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are described in Quality System documentation.. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head has a 0.7 mm aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The JJG Evolution™ Orthodontic implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards. This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ Monoblock Implant system is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.