FDA 510(k) Applications for Medical Device:
Cleanser, Root Canal

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K030884 ACADENTAL 5830 WOODSON ST.
MISSION KS 66202
K130180 CERKAMED WOJCIECH PAWLOWSKI KWIATKOWSKIEGO 1 STREET
STALOWA WOLA, PODKARPACIE 37-450
K032361 DENTSPLY INTL. 570 WEST COLLEGE AVENUE
YORK PA 17405-0872
K053167 DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER
YORK PA 17404
K103244 DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER
YORK PA 17404
K201785 EPIEN Medical, Inc. 4225 White Bear Parkway Suite 600
St. Paul MN 55110
K123538 EPIEN MEDICAL, INC. 700 THIRTEENTH ST. NW STUITE 200
WASHINGTON DC 20005
K140846 ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING STREET
SOUTH HACKENSACK NJ 07606
K072555 ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST.
SOUTH HACKENSACK NJ 07606
K070401 ESSENTIAL DENTAL SYSTEMS, INC. 55 NORTHERN BLVD., SUITE 200
GREAT NECK NY 11021
K150020 ESSENTIAL DENTAL SYSTESM, INC. 89 LEUNING STREET, SUITE 8
SOUTH HACKENSACK NJ 07606
K162311 INSTITUT STRAUMANN AG PETER MERIAN WEG 12
BASEL CH-4002
K211813 Inter-Med / Vista Dental 2200 South Street
Racine WI 53404
K112250 INTER-MED, INC. 2200 NORTHWESTERN AVE.
RACINE WI 53404
K082470 INTER-MED, INC. 2200 NORTHWESTERN AVE.
RACINE WI 53404
K193357 Inter-Med/ Vista Dental Products 2220 South Street Suite A
Racine WI 53404
K193409 Inter-Med/Vista Dental Products 2200 South St. Ste. A
Racine WI 53404
K992484 JORDCO, INC. 595 N.W. 167TH AVE.
BEAVERTON OR 97006
K141352 OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD
PETALUMA CA 94954
K160577 PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE
BREA CA 92821
K153528 PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE
Brea CA 92821
K151852 PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE
BREA CA 92821
K200330 Pac-Dent, Inc 670 Endeavor Circle
Brea CA 92821
K962743 PULPDENT CORP. 80 OAKLAND ST.
WATERTOWN MA 02472
K061689 PURICORE, INC. 320 KING OF PRUSSIA ROAD
RADNOR PA 19087
K063812 STRAUMANN USA 60 MINUTETEMAN ROAD
ANDOVER MA 01810
K003422 SUPER GLIDE, INC. 227 COLCHESTER AVE.
BURLINGTON VT 05401
K992919 SUPER GLIDE, INC. 227 COLCHESTER AVE.
BURLINGTON VT 05401
K024198 SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE.
ORANGE CA 92867
K173163 Ultradent Products, Inc. 505 W Ultradent Drive (10200 South)
South Jordan UT 84095
K063703 ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH
SOUTH JORDAN UT 84095
K060335 ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH
SOUTH JORDAN UT 84095
K032627 ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH
SOUTH JORDAN UT 84095




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