510(k) Report

Devices descending from K063523

4 later devices reach Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13, 16… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+1K091182Champions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000 UP to 6000Champions Implants GmbH20103—
+2K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+2K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—