Medical Device Manufacturer · US , Stamford , CT

Exacta Dental Direct, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2011

Recent clearances: Fixtemp Cement, FIXTEMP C&B

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Exacta Dental Direct, Inc. Dental ✕

2 devices

1-2 of 2

Cleared Jun 04, 2015

Cleared Jun 17, 2011

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 21, 2026