510(k) Report

Devices descending from K961719

3 later devices reach Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990458Straumann Extraoral Implant SystemStraumann USA19992—
+2K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.20161—
+3K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.20240—