Medical Device Manufacturer · US , Calabasas , CA

Implant Direct Sybron Manufacturing, LLC

17 submissions · 17 cleared · Since 2013
17
Total
17
Cleared
0
Denied

Implant Direct Sybron Manufacturing, LLC — FDA 510(k) Submissions

Implant Direct Sybron Manufacturing, LLC has submitted 17 FDA 510(k) premarket notifications since 2013, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Drill, Bone, Powered . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Guided Surgery Kit
K231087 · DZI Drill, Bone, Powered · General Hospital
Aug 2023 121d
SMARTbase Abutment System
K223535 · NHA Abutment, Implant,... · Dental
Jun 2023 209d
Implant Direct Dental Implant Systems Portfolio - MR Conditional
K222211 · DZE Implant, Endosseous,... · Dental
Feb 2023 192d
Standard Sterilizable Tray
K202524 · KCT Sterilization Wrap... · General Hospital
Jan 2021 149d
Simply Iconic Implants
K201553 · DZE Implant, Endosseous,... · Dental
Jan 2021 226d
Mini Sterilizable Tray
K200858 · KCT Sterilization Wrap... · General Hospital
Aug 2020 127d
Surgical Drills
K200265 · DZI Drill, Bone, Powered · Dental
Jun 2020 148d
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
K192221 · DZE Implant, Endosseous,... · Dental
Jun 2020 315d
Custom Legacy and Custom InterActive Titanium Abutments
K192218 · NHA Abutment, Implant,... · Dental
May 2020 267d
Legacy SMARTBase Abutments
K191458 · NHA Abutment, Implant,... · Dental
Oct 2019 132d
InterActive SMARTBase Abutments
K181359 · NHA Abutment, Implant,... · Dental
Aug 2018 85d
Custom Bars
K162633 · NHA Abutment, Implant,... · Dental
Jul 2017 306d
GPS Angled Abutment
K153509 · NHA Abutment, Implant,... · Dental
Aug 2016 263d
2014 InterActive/SwishActive System
K143011 · DZE Implant, Endosseous,... · Dental
Jul 2015 269d
InterActive Complete Surgical Tray
K142519 · KCT Sterilization Wrap... · General Hospital
Apr 2015 219d
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
K130572 · DZE Implant, Endosseous,... · Dental
Dec 2013 295d
LEGACY3 6MM LENGTH IMPLANTS
K131097 · DZE Implant, Endosseous,... · Dental
Aug 2013 126d
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