DENOPTIX MANUFACTURED BY GENDEX DENTAL SYSTEMS

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Request for Information Form	Contact Information
Company Name	GENDEX DENTAL SYSTEMS
Address	901 WEST OAKTON ST.
City, State, Zip	DES PLAINES, IL 60018
Country	US
FDA Owner/Operator Phone	202-828-0850
FDA Medical Specialty Code	RA - Radiology
FDA Product Code	EGY
FDA Classification Name	PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
FDA Device Classification Code	Standards
FDA Regulation Number	892.1900
FDA Common Generic Name	DENTAL IMAGING SYSTEM
FDA Proprietary Device Name	DENOPTIX
FDA Owner / Operator Number	9061616
FDA Owner / Operator Name	DANAHER CORPORATION
FDA Establishment Registration Number	1419870
FDA Registered Establishment Name	GENDEX DENTAL SYSTEMS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	04-07-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AIR TECHNIQUES, INC. 1295 WALT WHITMAN RD. MELVILLE, NY 11747 US 800-247-8324 / 516-214-5514	ALL PRO	ALL PRO
2	ALPHATEK CORP. 2000 SOUTH 25TH AVE. BROADVIEW, IL 60153 US 708-345-0500 / 708-345-0500	MULTIPLE	VARIOUS
3	SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. NO. 1/211 JIANGCHANG SAN RD., SHANGHAI, 200436 CH 86-21-51060178 / 408-252-3876	MULTIPLE	DENTAL X-RAY FILM PROCESSOR
4	SMITH COMPANIES DENTAL PRODUCTS 4368 ENTERPRISE ST. FREMONT, CA 94538 US 510-490-8999 / 510-490-8999	MULTIPLE	VARIOUS MODELS OF AUTOMATIC (DENTAL) RADIOGRAPIC FILM PROCESSORS
5	X-RAY SUPPORT INC. 3020 N. SULLIVAN RD. SUITE D SPOKANE VALLEY, WA 99216 US 509-242-1011 / 509-242-1011	DXSS AUTOMATIC X-RAY AUTOMATIC FILM PROCESSOR	DENTAL X-RAY AUTOMATIC FILM PROCESSOR