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The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.

The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. The temporary coping fits over the Straumann solid abulments and has radial projections that facilitate the retention of added acrylic or composite materials to form a temporary restoration.

Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite. Straumann Granules provide a bone void filler that is resorbed and replaced with bone during the healing process.

The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.

The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.

The MODUS® Titanium Osteosynthesis System is intended for use in oral, maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The MODUS® Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

The MODUS® System sagittal split plate with slider has a U-shaped design. It is available in two configurations, with six or eight screw holes. The plate is composed of CP Grade 1 titanium. The plate has a thickness of 0.7 mm and is available in a range of lengths of 31.65mm to 52.65 mm. The slider is 10 mm in diameter and is composed of Grade 4 CP titanium meeting ASTM F67.

The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the orgal cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.

The ITI Protection Healing Cap is a device which is mounted onto an 171 implant after the abutment has been placed into the implant and serves to protect the outer configuration of the abutment and which the clinician can modify to maintain and condition the precise contours of the soft tissue during the prosthetic phase. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The protection healing caps remain in place for approximately 2 weeks while the tinal restoration is being constructed. The ITI Protection Healing Cap is available in two sizes. The small cap has a diameter of 5.8 mm and a height of 4.0 mm. The large cap has a diameter of 6.2 mm and a height of 5.0 mm. The Profection Healing Caps are designed with a 65° bevel which extends 0.5 mm (small) to 0.7 mm (large) beyond the outer edge of the implant making it possible to modify the dimension of the caps. The ITI Protection Healing Caps are composed of Polyetheretherketone (PEEK) which is extruded from its granulated form and lathed to form the caps.

The esthetic healing caps are intended to protect the inner configuration of the M implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft fissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.

The ITI esthetic healing caps are titanium devices which are mounted onto an ITI implant before the soft tissue is sutured in place around the implant. These healing caps are intended to protect the inner configuration of the ITI implant and the 45s outer shoulder of the implant during the healing phase after the placement of the implant. The esthetic healing caps also serve to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing caps is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The esthetic healing cap remains in place for six to twelve weeks. The ITI esthetic healing cap is available in two heights (2.0 mm and 3.5 mm). Each cap consists of two parts: the body of the healing cap itself and a corresponding occlusal screw which aftixes the cap onto the implant. The healing caps and the occlusal screws are composed of commercially pure Grade 4 titanium meeting ASTM F67-95. The esthetic healing caps are designed with a bevel which should be positioned either labially or bucally. This bevel enables positioning of the mucoperiosted! flap over the esthetic healing cap after implant placement without subjecting the flap to tension.

The device is intended for surgical placement in maxillary and/ or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

The ITI Wide Diameter Implant is a one-stage root-form design made of commercially pure titanium Grade 4 conforming to ASTM Standard Specification F67. It differs from the previously cleared 11 4.1 mm Solid Screw Implant (K894595, K920769) only in the diameter. The portion of the implant intended to be implanted into bone has an anchorage surface of a titanium plasma-sprayed coating 20 - 30 um thick. The neck of the implant, intended to remain above the crest of the bone upon implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. It is 2.8 mm in height and tapers to 4.8 mm in diameter at the coronal end to permit all standard 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 4.1 mm Solid Screw Implant. For the junction between the primary part (the implant) and the secondary part (the abutment), a cone-screw construction is used, which helps ensure an accurate marginal tit within the implant, reducing risk of loosening or rotation of the abutment. All ITI abutments have a tapered cone-to-screw base which screws into the coronal portion of the implant and creates a mechanically locking triction fit (similar to Morse taper, a principle that has been used in machine shops for many years). The external shape of the ITI Wide Diameter Implant consists of a solid body of 4.95 mm diameter with an external spiral screw having a major diameter of 5.6 mm. The principal teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre bone, rather than parallel to the implant axis. The thread pitch and thread form are identical to those of the ITI 4.1 mm Solid Screw Implant. The most apical 2 mm of the implant and the first 1.5 mm below the crest of the bone have no threads. The apex has a near-hemispherical shape. The implant is manufactured in sink depths (the depth intended to be implanted into bone, excluding the 2.8 mm neck) of 8 and 10 mm. Accessories: The surgical technique intended for the implant includes initial use of the same IT 2.2 mm and 2.8 mm pilot drills as are used for other ITI solid screw implants, followed by The use of the standard ITI 3.5 mm twist drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, equivalent to AISI 440B) and include grooves to show the correct placement depth for each implant length. The depth gauge provided for use with the ITI Wide Diameter is made from austenitic stainless steel (DIN 1.4305, equivalent to AISI 303).