510(k) Report

Devices descending from K090234

22 later devices reach Spectra System Dental Implants 2008 through their predicates, nearest generation first.

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