Search Results

CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for the restoration of edentulous and partially edentulous jaws with prosthetic restorations such as implant-supported single crowns, bridges and full dentures. Specifically for: - · single-tooth gaps, - · partially edentulous jaws with several missing teeth or - · edentulous jaws. CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oral endosseous implantation in the maxillary and/or mandibular bone and are intended for immediate or delayed implantation. They are indicated for transgingival healing (one-stage, using healing caps or abutments) or subgingival healing (two-stage, using cover screws). If single-phase healing is intended, the implants can be loaded immediately if the primary stability achieved is adequate for functional loading. In conjunction with the corresponding abutments, the implants can be used for screw-retained or cemented restorations such as single crowns, bridges and full dentures. CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm have the following additional specific indications: Implants with a diameter of 3.3 mm are indicated as an alternative in cases where the alveolar ridge width is only 5-6 mm. Because of their lower tensile strength compared with larger diameter implants, they should only be used under the following conditions: - As single implants, they should be used only to replace mandibular incisors and/or . maxillary lateral incisors. - . An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions. - . Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø 3.3 mm must be taken into account. - . Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants. - . The healing time for diameter 3.3 mm implants is at least 12 weeks. CONELOG® implants with 7 mm length have the following additional specific indications: These Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

The CONELOG® PROGRESSIVE-LINE Implants and the CAMLOG® PROGRESSIVE-LINE Implants represent an extension of the range of implants which are based on the welldocumented technology used for implants offered by CAMLOG Biotechnologies GmbH / Altatec GmbH. Altatec GmbH CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are titanium (CPTi Grade 4), screw-form endosseous dental implants and have a conical outer geometry in the apical area. The outer implant surface is abrasive-blasted and acid-etched - medium rough surface (Promote® surface structure). The implant shoulder of the CONELOG®/CAMLOG® PROGRESSIVE-LINE implants is machined. CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are supplied in different diameters and lengths (See Table 1. below). The Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are placed surgically in the maxillary and/or mandibular bone and serve as anchors for functional and esthetic oral rehabilitations in partially and fully edentulous patients. The prosthetic rehabilitation is carried out with single crowns, bridges, or full arch prostheses, which are fastened to the implants by corresponding secondary parts (i.e. abutments). The implant-abutment connection consists either of a Tube-in-Tube™ configuration with three cams for abutment positioning and rotational stability (CAMLOG® PROGRESSIVE-LINE) or an inner conical section and an indexing section with three cams for abutment positioning and as an antirotational mechanism (CONELOG® PROGRESSIVE-LINE). This means that the respective implant-abutment connections are identical to the connections of the respective equivalent systems (i.e. CONELOG®/CAMLOG® prosthetic product lines). CAMLOG® CONELOG® PROGRESSIVE-LINE Implants are intended for one stage (transgingival / non-submerged) or two stage (submerged) protocols. The CONELOG® PROGRESSIVE-LINE implants are placed at bone level (epicrestally) and the CAMLOG® PROGRESSIVE-LINE implants are placed 0.4mm supracrestally. The CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are made of the same implant grade material as the predicate devices (commercially pure titanium. CPTi Grade 4. meeting the requirements of ASTM F67-13. Standard Specification for Unalloyed Titanium for Surgical Implant Applications). The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ISO 11137-1 Sterilization of healthcare products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW-LINE and CAMLOG® ROOT-LINE implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAMLOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture. CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and mandible for the purpose of supporting single ooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CONELOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture. CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with iSy CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are abutments with a prefabricated, precision interface (implant/abutment connection) and a screw channel suitable for the respective implant system. CAM Titanium Blanks are to be used by a CAMLOG validated milling center with CAD/CAM technology to fabricate a final finished customized abutment made of titanium alloy. Each patient-specific abutment is individually prescribed by the clinician as a temporary, permanent, single, or multi-unit abutment. Computer-aided manufacturing (CAM) techniques are used to process the cylinder portion above the implant connection into an individual abutment or healing cap/gingiva former design. The healing cap/gingival former is temporary and used during healing. Permanent abutments have straight and angled designs that can be used for crowns, bridges or overdentures. CAM Titanium Blanks are available for CAMLOG SCREW-LINE and ROOT-LINE implants fitting five implant diameters (3.3. 3.8. 4.3. 5.0. 6.0 mm), for CONELOG SCREW-LINE implants fitting four implant diameters (3.3. 3.8, 4.3, 5.0 mm), and for the iSy implants with one connection fitting three implant diameters (3.8, 4.4, 5.0 mm).

CAMLOG® and CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CAMLOG® and CONELOG® implants to support prostheses in the maxillary and/or mandibular arch. iSy® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with iSy implants to support prostheses in the maxillary and/or mandibular arch.

Abutment for Bridges is a straight abutment designed for multi-unit, cement-retained restorations. It is available with two gingival heights (0.8 and 2.0 mm) for CONELOG and iSy and one gingival height for CAMLOG. Abutment for Bridges is available for CAMLOG, CONELOG and iSy Implant Systems. It is available in five CAMLOG platform diameters (3.3 mm, 4.3 mm, 5.0 mm, and 6.0 mm), four CONELOG platform diameters (3.3 mm, 3.8 mm, 4.3 mm and 5.0 mm), and one iSy interface connection. The Temporary Abutment is a straight, one-piece titanium abutment for cement-retained provisional restorations. It is available in a non-indexed bridge version for CAMLOG, CONELOG and iSy, and an indexed crown version for CAMLOG implant system.

CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.

Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy" Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

iSy Implant System implants are self-tapping, root form, tapered endosseous dental implants made of titanium. The implant has a smooth machined surface in the transgingival portion, and a Promote surface on the endosseous portion. The subject device implants are provided in two lengths (7.3 and 16 mm) and three diameters (3.8, 4.4 and 5.0 mm). The subject device includes four abutment types, gingiva former, temporary abutment, Locator® and Esthomic Abutment. Abutments are compatible with all three diameters (3.8, 4.4 and 5.0 mm). The Esthomic abutment is available with three design angulations (0°, 15°, 20°). iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures.

CONELOG® Titanium base CAD/CAM - Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments. - The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.

CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.

iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The iSy Implant System is an endosseous dental implant system designed for ease of use. Each product package contains the components needed for implant placement, impression taking, gingival contouring, and temporization. Components available with the iSy Implant System include the implant base, cover cap, multifunctional cap, gingiva former, universal abutment and Titanium base CAD/CAM. The implants are provided in three diameters (3.8, 4.4 and 5.0 mm) and three lengths (9, 11, and 13 mm). The implant/abutment interface is identical for all sizes and, therefore, only one abutment connection is necessary. The implant base is a mount, supplied with the implant, that also can be used for temporary restoration. Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°. The cover cap, multifunctional cap and gingiva former are temporary abutments used during healing. The universal abutment and titanium base CAD/CAM are abutments used for final restoration. The iSy implants are made of unalloyed titanium, iSy implant base, universal abutment and Titanium base CAD/CAM are made of titanium alloy, and iSy cover cap, multifunctional cap and gingiva former are made of polyetheretherketone.

CONELOG® Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. CONELOG® Implants with 3.3 mm diameter have the following additional specific indications: These are an alternative in cases where the alveolar ridge width is only 5 - 6 mm. Because of their lower mechanical strength compared with larger diameter implants, they should only be used under the following conditions: - As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors. - An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions. - Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø 3.3 mm must be taken into account. - Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants. - The healing time for Ø 3.3 mm implants is at least 12 weeks. CONELOG® Implants with 7 mm length have the following additional specific indications: CONELOG® SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional. Abutment Indications for Use CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. Vario SR Indications for Use CONELOG® Vario SR components for crown and bridge restorations: - Occlusal screw-retained crown, bridge and bar constructions on CONELOG® implants in the anterior and posterior region of the maxilla and mandible CONELOG® Vario SR components for bar restorations: - Anchorage of implant-supported full dentures for the edentulous maxilla in conjunction with 4 or more CONELOG® implants and in the edentulous mandible in conjunction with 2 or 4 or more CONELOG® implants.

The purpose of this submission is to add an alternative to the CAMLOG® Implant System by the introduction of an implant line with a tapered implant abutment interface. The new line of implants and abutments is named the CONELOG® Implant System. The primary features of the current CAMLOG Implant System are a change from the tube-in-tube interface with a square cam design for anti-rotation to the tapered implant/abutment interface connection with three positioning cams and the addition of a 7.0 mm long implant. The three positioning cams of the CONELOG abutments are placed more apically on the abutment shaft but are comparable in design principle to the three positioning cams of the CAMLOG Implant System. All other design features of the system remain the same. The CONELOG implant system features an implant/abutment interface that includes a 7.5° taper with anti-rotation cams at the base of the connection. Components available with the CONELOG implant/abutment interface include the SCREW-LINE Promote® plus implant and cover screw, healing caps, Universal abutments, Telescope abutments, Esthomic" abutments, the Esthomice abutment inset, temporary abutments, Gold-plastic abutments, Logfit® abutments, ball abutments, bar abutments and Vario SR abutments. All components correspond to previously cleared CAMLOG components with the tube-in-tube interface.

CAMLOG® Vario SR components for crown and bridge restorations: - Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J and K article numbers) in the anterior and posterior region of the maxilla and mandible CAMLOG® Vario SR components for bar restorations: - Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)

CAMLOG® Vario SR Abutments are titanium dental implant abutments for use with the CAMLOG® Dental Implant System. They have an internal connection to the implant, a conical interface with the prosthetic attachment, and are used for single and multi-unit screw-retained, prefabricated restorations. They are appropriate for supporting laboratory cast frameworks as well as laser-welded bar constructions and have dedicated prosthetic components.

CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.