Medical Device Manufacturer · US , New York , NY

Coltene/Whaledent, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1991

Official Website

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coltene/Whaledent, Inc. Dental ✕

18 devices

1-12 of 18

Cleared Oct 18, 2007

PERFECT TISSUE CONTOURING SYSTEM II

Cleared Mar 15, 2004

COLTOLUX LED CURING LIGHT

Cleared Jan 23, 2004

ONE COAT SE BOND

Cleared Aug 05, 2003

Cleared Dec 10, 2001

Cleared Nov 30, 2000

COLTENE AURA COMPOMER RESTORATIVE SYSTEM

Cleared Apr 14, 2000

TENAX WHITE POST

Cleared Mar 14, 2000

PARAPOST FIBER WHITE

Cleared Dec 21, 1999

MODIFICATION OF PARAPOST CEMENT

Cleared Jan 20, 1999

BIOSONIC ULTRASONIC SCALER SYSTEM

Cleared Mar 24, 1998

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM

Cleared Mar 09, 1998