Medical Device Manufacturer · US , Morris Plains , NJ

Orasystems - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2000

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orasystems Dental ✕

3 devices

1-3 of 3

Cleared Dec 04, 2000

Cleared Oct 05, 2000

Cleared Sep 27, 2000

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 28, 2026