FDA 510(k) Applications Submitted by Reina Choi
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200265 |
02/03/2020 |
Surgical Drills |
Implant Direct Sybron Manufacturing, LLC |
| K200858 |
04/01/2020 |
Mini Sterilizable Tray |
Implant Direct Sybron Manufacturing, LLC |
| K231087 |
04/17/2023 |
Guided Surgery Kit |
Implant Direct Sybron Manufacturing, LLC |
| K181359 |
05/22/2018 |
InterActive SMARTBase Abutments |
Implant Direct Sybron Manufacturing LLC |
| K191458 |
05/31/2019 |
Legacy SMARTBase Abutments |
Implant Direct Sybron Manufacturing LLC |
| K201553 |
06/10/2020 |
Simply Iconic Implants |
Implant Direct Sybron Manufacturing, LLC |
| K222211 |
07/25/2022 |
Implant Direct Dental Implant Systems Portfolio - MR Conditional |
Implant Direct Sybron Manufacturing LLC |
| K192218 |
08/15/2019 |
Custom Legacy and Custom InterActive Titanium Abutments |
Implant Direct Sybron Manufacturing , LLC |
| K192221 |
08/15/2019 |
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts |
Implant Direct Sybron Manufacturing, LLC |
| K202524 |
09/01/2020 |
Standard Sterilizable Tray |
Implant Direct Sybron Manufacturing, LLC |
| K162633 |
09/21/2016 |
Custom Bars |
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
| K223535 |
11/23/2022 |
SMARTbase Abutment System |
Implant Direct Sybron Manufacturing LLC |
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