Search Results

The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement. The XiVE®S PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement. The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26. The XiVE® TG PLUS Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The ANKYLOS® Dental Implant System consists of threaded dental implants in 3.5 - 7.0 mm diameters with 8 - 17 mm lengths. The implants are coated with the FRIADENT Surface. The ANKYLOS® Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. In the edentulous mandible, the ANKYLOS® dental implants are indicated for immediate loading procedures using the standard protocol.

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling.

The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.

The XiVE® TG Abutment is part of the XiVE® TG Transgingival Dental Implant System. The XIVE® TG Abutment is intended for the fabrication of screwretained or cementable crowns and bridges. The XiVE® TG Abutment is constructed of CP-2 titanium and is available in a 3.4 - 4.5mm diameter to correspond to the XiVE® transgingival implant bodies. The XiVE® TG Abutment is available with a straight or angled configuration.

The FRIALIT®-2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The FRIALIT®-2 Dental Implant System consists of subgingival threaded dental implants in 3.4 - 6.5mm diameters with 8 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The FRIALIT®-2 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures.

The XiVE® Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® Dental Implant System consists of subgingival threaded dental imolants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures. In the edentulous mandible, the XiVE® dental implants are indicated for immediate loading procedures using the standard protocol.

The XiVE® TG Dental Implant System is indicated for singlestage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular spinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimu of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (> 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® TG Dental Implant System consists of transgingival threaded dental implants in 3.4 -4.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® TG Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for splinted crowns, bridges and complete dentures. In the edentulous mandible, the XiVE® TG transgingival dental implants are indicated for immediate loading procedures using the standard protocol.

The XiVE® Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns. bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants ≥ 9.5mm are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

The XiVE® Transgingival Dental Implant System consists of transgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 -- 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE® Transgingival Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading indications in the edentulous mandible.

FRIOS® ALGIPORE® is indicated for: - Treatment of intrabony defects . - Augmentation of bony defects of alveolar ridge . - Filling of extraction sites ● - Sinus elevation grafting .

FRIOS® ALGIPORE® is a bone filling and augmentation material indicated for use in dental applications. FRIOS® ALGIPORE® is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. FRIOS® ALGIPORE® is provided sterile in pre-filled vials and has a granular size range from 300 - 2000 microns.

The XiVE Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading procedures using four implants in the anterior mandible.