Medical Device Manufacturer · US , Hoboken , NJ

Rhein 83 Srl - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2004

Recent clearances: OT EQUATOR, OT EQUATOR, OT EQUATOR

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rhein 83 Srl Dental ✕

4 devices

1-4 of 4

Cleared Apr 09, 2018

Cleared Aug 11, 2016

Cleared Nov 25, 2015

Cleared Apr 21, 2004

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

Data Source

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

Last updated: Jun 08, 2026