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REVOIS PRO Implant System is an implant system recommended for surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges, or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading (with good primary stability and appropriate occlusal loading) or in a two-stage surgical procedure (after osseointegration of the implant).

The REVOIS® PRO Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® PRO Implant System is composed of a titanium screw type cylindrical implant. It is a screw form implant with cylindrical thread and a progressive thread near the apex. The double thread of the implant body is contiguous with the triple thread (fine thread) at the implant neck. Together with the conical implant body of the REVOIS®: PRO implant, the progressive thread makes sure that the implant is well anchored in the host bone of the alveolar crest. The incremental pitch of the thread upwards evenly distributes the forces so that implants heal well and can be loaded immediately. The implant system is delivered in a sterile insert blister and comprises an implant, an impression abutment, an impression screw and a cover screw (sterile packed as a set in a blister packaging). The impression screw serves as a connector between impression abutment and implant so that the pre-assembled parts fit tightly into the inlay for sterility reasons. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). For ease of identification the implants are color coded according to diameter. The dental abutment portions of the REVOIS® : PRO implant system include several abutments described subsequently: - Healing Abutments of diameter 4.4 mm and 5.2 mm in height 2 mm, 3mm and 5 mm each, made of Titanium Grade 5 - Standard abutment (incl. retaining screw) of diameter 4,4 mm in height 5 mm and 7 mm each, made of Titanium Grade 5 - Individual aesthetic abutment of diameter 4,4 mm, made of CERAMICOR®, a gold- platinium alloy - Impression abutment, multi (pre-mounted with impression screw) made of Titanium Grade 5 - Impression abutment open tray of diameter 4.4 mm, made of Titanium Grade 5 - Locator* abutment, made of Titanium Grade 5 - Locatore Replacement set, consists of several components made of plastic and Titanium Grade 5 - Locator® impression coping, made of the Aluminium Alloy 6061 - Dalbot ball attachment of diameter 4.4 mm and in height 3 mm and 5mm, made of Titanium Grade 5 The REVOIS® PRO Implant System is provided with a variety of prosthetic components and tool which are definitely 510(K)-exempt or still cleared by the submission K063106. The main components of the implant system are made of Grade V Titanium (implant, abutment). The materials comply with the ASTM standards ASTM F067 (implant) and ASTM F0136-2a (abutment). The implant surface is blasted with luminium oxide particles (Corundum) and then acid-etched for micro-roughness. The REVOIS® PRO titanium implant is sterile packed for single use only. The sterility is indicated by the color on the sterility indicator attached to the inner Tyvek® foil.

The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

The REVOLS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components which are definitely 510(K)-exempt or still cleared by the submission K063106. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade V Titanium. The used materials comply with the ASTM standards ASTM F067, ASTM F0136-2a, and ASTM F2026. The implant surface is blasted with aluminium oxide and then acid-etched for microroughness. Blasting and acid -etching contributes to the implant surface characteristics. Furthermore grooves increase resistance to shear forces in difficult clinical cases. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.

CERASORB® Plus is recommended for: - · Defects after extirpation of bone cysts - · Augmentation of the atrophied jaw ridge - · Sinus lift or sinus base elevation respectively - · Filling alveolar defects after tooth extraction for jaw ridge support - · Filling extraction defects to create an implant site - · Filling of two or multi-walled infrabony pockets, and bifurcation and trifurcation defects - · Defects after operative removal of retained teeth or corrective osteotomes

CERASORB® Plus is a sterile, synthetic, porous and biocompatible ceramic matrix roundish and polygonal crushed shaped morsels. This modification consists of purephase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® Plus mixture of granules with porosity of 35% and of 65%). CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic. In contact with vital bone the CERASORB® Plus granules, morsels or granulate is reabsorbed and gradually replaced by new bone. CERASORB® Plus is provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only. The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the vears. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size.