510(k) Report

Devices descending from K150182

18 later devices reach Neodent Implant System- CM Drive Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+1K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+1K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+2K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+2K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+2K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+3K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+3K243278Custom AbutmentsInstitut Straumann AG202501
+3K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+3K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+3K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+3K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+4K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—