510(k) Report

Devices descending from K060957

5 later devices reach Modification to Blue Sky Bio Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+1K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—