Medical Device Manufacturer · US , Cuyahoga Falls , OH

Coltene/Whaledent GmbH & Co. KG - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2003

Recent clearances: STAY-PUT IMPREGNATED, GUTTAFLOW

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coltene/Whaledent GmbH & Co. KG Dental ✕

2 devices

1-2 of 2

Cleared Jun 15, 2004

STAY-PUT IMPREGNATED

Cleared Nov 03, 2003

Data Source

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

Last updated: Oct 11, 2026