COLTENE/WHALEDENT INC. - CUYAHOGA FALLS, OH

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FDA-Registered Company Profile for COLTENE/WHALEDENT INC.

FDA-Supplied Establishment Information:

Establishment Registration Number:

2416455

Company Name:

COLTENE/WHALEDENT INC.

Also Known As:

WHALEDENT
COLTENE, INC.
HYGENIC
COLTENE

Address:

235 ASCOT PARKWAY

Address 2:

City:

CUYAHOGA FALLS

State

Zip / Postal Code:

44223

County:

SUMMIT

Country:

Establishment Operation Code(s):

AA - Initial Distributor
ME - Contract Manufacturer
MM - Manufacturer

Establishment Status Code:

A - Active

Year of Most Recent Initial
or Annual Registration:

2007

FDA-Supplied Owner/Operator Information:

Owner/Operator Number:

9089944

Company Name:

MEDISIZE HOLDING AG

Address:

WATTWIL

Address 2:

City:

WATTWIL

State:

Zip / Postal Code:

CH-9630

Country:

Owner/Operator Phone:

41-71-987-1010

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

MR. ELLIS IVAN

Company Name:

COLTENE/WHALEDENT INC.

Address:

235 ASCOT PARKWAY

Address 2:

City:

CUYAHOGA FALLS

State:

Zip / Postal Code:

44223

Country:

Official Corespondent Phone Number:

330-916-8858

Other Establishment Information:

Establishment Phone:

Fax:

General Email:

Web Site:

Company Brochure:

Keywords:

Company Description:

Services Offered:

About Us:

Differentiation:

FDA-Registered Products Offered by COLTENE/WHALEDENT INC.
	Common Device Name	Proprietary Device Name
1	ATTACHMENT	TACH - EZ, DAWSON
2	AUXILLIARY RETENTION PIN	MULTIPLE PRODUCT NAMES
3	CALCIUM HYDROXIDE CAVITY LINER	CALCIO BIOTIC ROOT CANAL SEALER (CRCS)
4	COLLAR AND CROWN SCISSORS	COLLAR AND CROWN SCISSORS
5	CURING LIGHT	MULTIPLE PRODUCT NAMES
6	CUSTOM TRAY MATERIAL	HYGON TRAY MATERIAL
7	DAM NAPKINS	ORA SHIELD
8	DAM PUNCH	DENTAL DAM PUNCH
9	DENTAL BUR	ALPEN SPEEDSTER, ALPEN CARBIDE
10	DENTAL DAM	MULTIPLE PRODUCT NAMES
11	DENTAL DRILL	MULTIPLE PRODUCT NAMES
12	DENTAL ELECTROSURGE	MULTIPLE PRODUCT NAMES
13	DENTIN/ENAMEL BONDING SYSTEM	A.R.T BOND DENTAL/ENAMEL BONDING SYSTEM & ACCESSORIES
14	DENTURE BASE RESIN	MULTIPLE PRODUCT NAMES
15	DEPTH GAUGE	OMNI DEPTH GAUGE
16	DIRECTOR	LIGATURE DIRECTOR
17	DRY HEAT STERILIZER	DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
18	ENDODONTIC POST	MULTIPLE PRODUCT NAMES
19	EVACUATION SYSTEM	VAC-EJECTOR
20	EXPLORER	EXPLORER
21	EXPLORER	EXPLORER
22	GUTTA PERCHA	MULTIPLE PRODUCT NAMES
23	HEMOSTAT	MATHIEU HEMOSTAT
24	IMPRESSION TRAY	PRESIDENT TRAY
25	INSTRUMENT CASSETTE	BIOSONIC UC-70 STERILIABLE INSTRUMENT CASSETTE
26	INSTRUMENT CASSETTE	MULTIPLE PRODUCT NAMES
27	PAPER POINTS	MULTIPLE PRODUCT NAMES
28	PLIER	PLIERS, MULTIPLE
29	PLUGGER	HYFLEX FINGER PLUGGER
30	RIGHT ANGLE HANDPIECE AND HEAD	MULTIPLE PRODUCT NAMES
31	RIGHT ANGLE HANDPIECE: HEAD, R.A. HDPCE	NO PROPRIETARY NAME LISTED
32	RUBBER DAM CLAMP	MULTIPLE PRODUCT NAMES
33	RUBBER DAM CLAMP FORCEPS	MULTIPLE PRODUCT NAMES
34	RUBBER DAM FRAME	MULTIPLE PRODUCT NAMES
35	SCALER	BIOSONIC ULTRASONIC SCALER SYSTEM
36	SEALER	CALCIO BIOTIC ROOT CANAL SEALER
37	SPREADER	HYFLEX FINGER SPREADER
38	TEMPORARY CROWN & BRIDGE MATERIAL	COOL TEMP
39	THERMAL PULP TESTER	ENDO-ICE PULP TESTER, THERMAL
40	TWEEZERS	ANTERIOR BONDING TWEEZERS
41	ULTRASONIC CLEANER SYSTEM	MULTIPLE PRODUCT NAMES
42	VARIOUS MATERIAL, TOOTH SHADE, RESIN PRODUCTS	MULTIPLE PRODUCT NAMES
43	WAX	MULTIPLE PRODUCT NAMES
All FDA-Registered products for this company are displayed above.

Other Products Offered by COLTENE/WHALEDENT INC.:

No products have been listed by this company.

Services Offered by the COLTENE/WHALEDENT INC.:
No services have been listed by this company.

Additional Contact Information for COLTENE/WHALEDENT INC.:
There is no additional contact information for this company.

FDA-Registered Company Profile for COLTENE/WHALEDENT INC.

FDA-Registered Products Offered by COLTENE/WHALEDENT INC.

Other Products Offered by COLTENE/WHALEDENT INC.:

Services Offered by the COLTENE/WHALEDENT INC.:

Additional Contact Information for COLTENE/WHALEDENT INC.:

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