510(k) Report

Devices descending from K160119

7 later devices reach NobelSpeedy Groovy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+1K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+1K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+2K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+2K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+3K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+3K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—