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The Cresco Ti® Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single toolh implantation use.

The proposed system which is the subject of this Special 510(k) Notification, is a modification to the existing Cresco Ti implant concept, which has been previously cleared by the FDA under 510(k) Number K981052 on December 18, 2001. This exaced includes a single non-sterile package containing all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories which are compatible with non-Cresco Ti endosseous implants. Modifications have been made to apply the same concept as that used for the Cresco . Hourient system to other inplant interfaces other than those included on page 134 of the original 510(k) Notification K980152. Additional bridge supports are included in this 510(k) Notification which are designed to fit a broader range of implant interfaces. In addition, the Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g. procious metal, Co-Cr),