Medical Device Manufacturer · US , Mahwah , NJ

Coltene AG - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2002

Recent clearances: COOL TEMP NATURAL, COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coltene AG Dental ✕

2 devices

1-2 of 2

Cleared May 13, 2004

COOL TEMP NATURAL

Cleared Sep 18, 2002

COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM