510(k) Report

Devices descending from K190958

5 later devices reach Neodent Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+1K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+2K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+2K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+2K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—