510(k) Report

Devices descending from K212785

3 later devices reach Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+1K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+1K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—