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Intended for use in reconstruction of natural or surgical periodontal defects of the oral and maxillofacial region, including sinus floor elevation and augmentation of the alveolar crest. Intended for filling into the site of a bony defect in combination with patient blood, autologous bone, membranes or sterile saline after removal of cysts or surgical removal of retained teeth.

ArrowBone-B consists of high purity Tricalcium Phosphate Ceramics of which the Ca/P ratio is 1.50. It is manufactured by a validated manufacturing process which guarantees pure-phase materials depending on the sintering temperature. This process is illustrated in Appendix I. Basically, it involves the well-established methods of wet synthesis from phosphoric acid and calcium hydroxide in dilute solution, spray drying to make spherical aggregates, calcination of the aggregates, x-ray diffraction analysis/identification of impurities, removal of fines by sieving, and molding of the particles into porous granules. These are then sintered at the selected temperature for the product which incinerates and removes the binder, hydroxypropyl cellulose, for which the specifications are shown in Appendix 1.6. The chemical composition of this material is shown. It can be identified by x-ray powder diffraction analysis as pure-phase beta-Tricalcium Phosphate Ceramic in ArrowBone-B. The diffraction analysis is provided.. The identifying peaks as shown on these patterns for ßtricalcium phosphate are indicated by open circles. These data show that the crystalline structure of ArrowBone-B is pure-phase beta-Tricalcium Phosphate

Cleaning, polishing and restoring natural esthetics of tooth enamel.

The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm

Mytis Arrow XXXX systems are intended for immediate placement in extraction or surgically prepared sites in partially or fully edentulous mandibles and maxillae (type 1 or II bone), in support of single or multiple-unit restorations including; cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Mytis Arrow Implant system comprises various sets of root form endosseous dental implants and compatible implant abutment systems. Mytis Arrow Systems are designed for use in dental implant surgery and are intended to be used in a manor in which the implant integrates with the bone. The Mytis Arrow abutments include various abutments designed to enable the implant process from healing through final restoration. Mytis implants are for single and two-stage surgical procedures.