Implant Direct Sybron Manufacturing, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Implant Direct Sybron Manufacturing, LLC - FDA 510(k) Cleared Devices
Recent clearances: Guided Surgery Kit, SMARTbase Abutment System, Implant Direct Dental Implant Systems Portfolio - MR Conditional
17
Total
17
Cleared
0
Denied
Implant Direct Sybron Manufacturing, LLC has 17 FDA 510(k) cleared dental devices. Based in Calabasas, US.
Last cleared in 2023. Active since 2013.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hogan Lovells US LLP, Hogan Lovells Llp and Hogan & Lovells U.S. Lpp.
FDA 510(k) Regulatory Record - Implant Direct Sybron Manufacturing, LLC
17 devices
Cleared
Aug 16, 2023
Guided Surgery Kit
General Hospital
121d
Cleared
Jun 20, 2023
SMARTbase Abutment System
Dental
209d
Cleared
Feb 02, 2023
Implant Direct Dental Implant Systems Portfolio - MR Conditional
Dental
192d
Cleared
Jan 28, 2021
Standard Sterilizable Tray
General Hospital
149d
Cleared
Jan 22, 2021
Simply Iconic Implants
Dental
226d
Cleared
Aug 06, 2020
Mini Sterilizable Tray
General Hospital
127d
Cleared
Jun 30, 2020
Surgical Drills
Dental
148d
Cleared
Jun 25, 2020
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants
Dental
315d
Cleared
May 08, 2020
Custom Legacy and Custom InterActive Titanium Abutments
Dental
267d
Cleared
Oct 10, 2019
Legacy SMARTBase Abutments
Dental
132d
Cleared
Aug 15, 2018
InterActive SMARTBase Abutments
Dental
85d
Cleared
Jul 24, 2017
Custom Bars
Dental
306d