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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.

This is a pre-amendment 510k submission for a medical device from 1996. The provided text is a 510(k) Summary, which is a regulatory document to demonstrate substantial equivalence to legally marketed devices. It outlines the device's features and intended use but does not contain information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or expert involvement. These types of details are typical for modern AI/ML device submissions, which did not exist at the time this document was created.

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