510(k) Report

Devices descending from K050641

20 later devices reach Zygoma Tiunite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243834NobelZygoma TiUltra Implant systemNobel Biocare AB20250—
+1K070182Zygoma Implant (Immediate Function)Nobel Biocare AB200719—
+2K152093NobelZygoma 45°Nobel Biocare AB20163—
+2K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+2K093562Endosseous Dental ImplantSouthern Implants, Inc.201010—
+3K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K161598NobelZygoma 0°Nobel Biocare AB20172—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K183069NobelZygoma 0°Nobel Biocare AB20180—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—