510(k) Report

Devices descending from K013277

26 later devices reach Astralis 7, Model 557545 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073033Legacy Dental ImplantsImplant Direct, LLC200725—
+2K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+2K153650Microdent Ektos Implant SystemImplants Microdent System S.L20160—
+2K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+2K090234Spectra System Dental Implants 2008Implant Direct, LLC20092211
+3K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC20250—
+3K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+3K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+3K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+3K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+3K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+4K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+4K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+4K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+6K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+6K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—