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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
DENTICATOR INTL., INC.
EARTH CITY,  MO,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
YOUNG INNOVATIONS, INC.
EARTH CITY,  MO ,  US.
DENTICON INTERNATIONAL INC.
NOGALES,  AZ,  US.
Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
DENTICON, S.A. DE C.V.
NOGALES, SONORA,  MX.
Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
DENTILAB, S.A. DE C.V.
SAN BEUNAVENTURA, PANZACOLA,  MX.
Manufacturer;  
DENTILAB, S.A. DE C.V.
MEXICO CITY,  MX.
DENTING SALES, LTD.
DAUPHIN, MANITOBA,  CA.
Foreign Exporter;  
DENTING SALES, LTD.
DAUPHIN, MANITOBA,  CA.
DENTIO CO., LTD.
ANYANG CITY, KYUNGGI-DO,  KS.
Unregistered Foreign Lister;  
DENTIO CO., LTD.
ANYANG CITY, KYUNGGI-DO,  KS.
DENTIST PREFERRED, INC.
YARDLEY,  PA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTIST PREFERRED, INC.
WASHINGTON CROSSING,  PA ,  US.
DENTISTS CHOICE, INC.
COMBS,  KY,  US.
Repackager/Relabeller;  
DENTISTS CHOICE, INC.
LEXINGTON,  KY ,  US.
DENTIUM CO., LTD.
SUWON-SI, GYEONGGI-DO,  KS.
Manufacturer;  
DENTIUM CO., LTD.
SUWON-SI, GYEONGGI-DO,  KS.
DENTIUM CO., LTD.
CYPRESS,  CA,  US.
Initial Importer;  
DENTIUM CO., LTD.
SUWON-SI, GYEONGGI-DO,  KS.
DENTLIGHT INC.
RICHARDSON,  TX,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DENTLIGHT INC.
RICHARDSON,  TX ,  US.
DENT-LINE OF CANADA, INC.
LORETTO, ONTARIO,  CA.
Manufacturer;  
DENT-LINE OF CANADA, INC.
LORETTO, ONTARIO,  CA.
DENTMAX
VALINDA,  CA,  US.
Manufacturer;  
DENTMAX
VALINDA,  CA ,  US.
DENT'N CO
VILLEURBANNE,  FR.
Manufacturer;  
DENT'N CO
VILLEURBANNE,  FR.
DENTOMAL
MOSCOW REGION,  RS.
Unregistered Foreign Lister;  
DENTOMAL
MOSCOW REGION,  RS.
DENTONICS, INC.
MONROE,  NC,  US.
Repackager/Relabeller;  
DENTONICS, INC.
MONROE,  NC ,  US.
DENTOPLAST S.A.R.L.
BOUCHRIEH INDUSTRIAL CITY,  LE.
Manufacturer;  
DENTOPLAST S.A.R.L.
BOUCHRIEH INDUSTRIAL CITY,  LE.
DENTO-PROFILE SCALE CO.
CORONADO,  CA,  US.
Manufacturer;  
DENTO-PROFILE SCALE CO.
CORONADO,  CA ,  US.
DENTORIUM PRODUCTS CO., INC.
NEW YORK,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
DENTORIUM PRODUCTS CO., INC.
NEW YORK,  NY ,  US.
DENTOV LTD.
LONDON, N.W.,  UK.
Manufacturer;  
DENTOV LTD.
LONDON, N.W.,  UK.
DENTOVATIONS, INC.
BOSTON,  MA,  US.
Specification Developer;  
DENTOVATIONS, INC.
BOSTON,  MA ,  US.
DENTOX LTD.
WARWICKSHIRE,  UK.
Specification Developer;  
DENTOX LTD.
WARWICKSHIRE,  UK.
DENTRAMAR BV
WAALWIJK,  NT.
Unregistered Foreign Lister;  
DENTRAMAR BV
WAALWIJK,  NT.
DENTRIX
AMERICAN FORK,  UT,  US.
Manufacturer;   Specification Developer;  
DENTRIX
AMERICAN FORK,  UT ,  US.
DENTRONIX INC.
CUYAHOGA FALLS,  OH,  US.
Initial Importer;  
COLTENE/WHALEDENT INC.
CUYAHOGA FALLS,  OH ,  US.
DENTSHOP A/S
SANDNES,  NO.
Unregistered Foreign Lister;  
DENTSHOP A/S
SANDNES,  NO.
DENTSPLY BRAZIL
PETROPOLIS, R.J.,  BR.
Manufacturer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY CAULK
MILFORD,  DE,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY DENTAL (TIANJIN) CO., LTD.
TIANJIN ECONOMIC DVLP AREA,  CH.
Foreign Exporter;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY DETREY-DEDENT
KONSTANZ,  GM.
Manufacturer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY FRIADENT CERAMED
LAKEWOOD,  CO,  US.
Initial Importer;   Manufacturer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY GAC INTERNATIONAL
BOHEMIA,  NY,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PHARMACEUTICAL
YORK,  PA,  US.
Initial Importer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PREVENTIVE CARE
YORK,  PA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PROFESSIONAL
DES PLAINES,  IL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PROFESSIONAL
YORK,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PROSTHETICS
BURLINGTON,  NJ,  US.
Specification Developer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PROSTHETICS
LAS PIEDRAS,  PR,  US.
Manufacturer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY PROSTHETICS
YORK,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY RINN
ELGIN,  IL,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.

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Last Modified: 29 April 2006
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