FDA 510(k) Applications for Medical Device:
Agent, Polishing, Abrasive, Oral Cavity

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K962370 CHALLENGE PRODUCTS, INC. 333 WEST WACKER DRIVE,
CHICAGO IL 60606
K042048 DEEPAK PRODUCTS, INC. 5220 NW 72ND AVE., BAY #15
MIAMI FL 33166
K121698 DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST.
YORK PA 17404
K983966 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405
K000169 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K033785 DISCUS DENTAL, INC. 8550 HIGUERA ST.
CULVER CITY CA 90232-2522
K171189 E.M.S. Electro Medical Systems S.A. Chemin de la Vuarpilliere 31
Nyon ch-1260
K070854 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K042200 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K990482 MINNESOTA MINING AND MFG. CO. 3M CENTER
ST. PAUL MN 55144-1000
K041371 NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD, # 23
ALACHUA FL 32615
K002989 ORTEK THERAPEUTICS, INC. 305 MADISON AVE.
NEW YORK NY 10165
K062502 OSPRAY, LTD. 700 THIRTEENTH STREET NW
WASHINGTON DC 20005
K103114 OSSPRAY LTD HODGKIN BUILDING
LONDON SE1 1UL
K973289 PACIFIC RIM DENTAL, INC. 173CD SHADY LN.
STATELINE NV 89449
K040661 PASCAL CO., INC. 2929 N.E. NORTHUP WAY
BELLEVUE WA 98004
K040988 PASCAL CO., INC. 2929 N.E. NORTHUP WAY
BELLEVUE WA 98004
K062166 PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR.
PLYMOUTH MEETING PA 19462
K100539 PREVENTIVE TECHNOLOGIES, INC. 4330 MATHEWS-INDIAN TRAIL ROAD
INDIAN TRIAL NC 28079
K033449 PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC 500 WHITE DR.
BATESVILLE AR 72501
K102053 SUNSTAR AMERICAS, INC. 10 E. SCANTON AVE SUITE 201
LAKE BLUFF IL 60044
K024343 USBIOMATERIALS CORP. 13709 PROGRESS BLVD.
ALACHUA FL 32615
K101104 VOCO GMBH ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472
K131760 WHIP-MIX CORP. 361 FARMINGTON AVE.
LOUISVILLE KY 40217




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