Medical Device Manufacturer · US , Woburn , MA

Open Implants, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2020

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Open Implants, LLC Dental ✕

4 devices

1-4 of 4

Cleared Jun 26, 2025

Cleared Jun 21, 2022

Cleared Nov 30, 2021

Cleared Mar 24, 2020

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026