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.

The provided text is a 510(k) Premarket Notification from the FDA for dental implants. It does not describe an AI medical device or a study that uses a test set, expert ground truth, or addresses human-in-the-loop performance. Therefore, I cannot generate the requested information about acceptance criteria and study details for an AI medical device.

The document focuses on demonstrating substantial equivalence of the "Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants" to existing legally marketed predicate devices. The "Summary of Testing" section (page 7-8) details mechanical fatigue testing, sterilization validation, endotoxin testing, and accelerated aging for shelf-life, which are relevant to the physical and biological properties of the dental implants, not AI performance.

To provide the requested information, I would need a document describing an AI medical device and its performance study.

Ask a specific question about this device