510(k) Report

Devices descending from K050406

234 later devices reach Nobelspeedy Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+6K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—