Coltene/Whaledent, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Coltene/Whaledent, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
Coltene/Whaledent, Inc. has 21 FDA 510(k) cleared dental devices. Based in New York, US.
Historical record: 21 cleared submissions from 1991 to 2007.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Coltene/Whaledent, Inc.
21 devices
Cleared
Oct 18, 2007
PERFECT TISSUE CONTOURING SYSTEM II
Dental
126d
Cleared
Aug 04, 2005
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
General Hospital
43d
Cleared
Mar 15, 2004
COLTOLUX LED CURING LIGHT
Dental
13d
Cleared
Jan 23, 2004
ONE COAT SE BOND
Dental
52d
Cleared
Aug 05, 2003
COLTOSOL F
Dental
61d
Cleared
Dec 10, 2001
SYNERGY FLOW
Dental
56d
Cleared
Nov 30, 2000
COLTENE AURA COMPOMER RESTORATIVE SYSTEM
Dental
63d
Cleared
Apr 14, 2000
TENAX WHITE POST
Dental
178d
Cleared
Mar 14, 2000
PARAPOST FIBER WHITE
Dental
42d
Cleared
Dec 21, 1999
MODIFICATION OF PARAPOST CEMENT
Dental
48d
Cleared
Dec 16, 1999
PARAPOST SYSTEM STERILIZABLE ORGANIZER
General Hospital
34d
Cleared
Dec 06, 1999
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
General Hospital
69d
Cleared
Jan 20, 1999
BIOSONIC ULTRASONIC SCALER SYSTEM
Dental
90d
Cleared
Mar 24, 1998
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
Dental
83d
Cleared
Mar 09, 1998
SYNERGY
Dental
103d
Cleared
May 24, 1995
COLTOLUX 3, COLTOLUX 4
Dental
188d
Cleared
May 24, 1995
COLTOLUX LIGHT METER
Dental
133d
Cleared
Feb 02, 1995
PARAPOST CEMENT
Dental
104d
Cleared
Jun 06, 1994
PARAPOST XT SYSTEM
Dental
284d
Cleared
Aug 03, 1992
COLTENE A.R.T. BOND
Dental
62d
Cleared
Jul 25, 1991
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
Dental
51d