510(k) Report

Devices descending from K101545

15 later devices reach Genesis Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+1K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+1K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+1K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+1K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+1K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+1K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+2K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+2K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+2K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+3K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—