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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
DENTAL THERAPEUTICS AB
SALTSJO-BOO,  SW.
Manufacturer;  
DENTAL THERAPEUTICS AB
SALTSJO-BOO,  SW.
DENTAL USA, INC.
MCHENRY,  IL,  US.
Manufacturer;  
DENTAL USA, INC.
MCHENRY,  IL ,  US.
DENTAL VENTURES OF AMERICA, INC.
CORONA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DENTAL VENTURES OF AMERICA, INC.
CORONA,  CA ,  US.
DENTAL VIDEO SYSTEMS, INC.
COLERIDGE,  NE,  US.
Manufacturer;  
JAMES G. LITEL
COLERIDGE,  NE ,  US.
DENTAL WORKS INTERNATIONAL, INC.
BINAN, LAGUNA,  RP.
Manufacturer;  
DENTAL WORKS INTERNATIONAL, INC.
BINAN, LAGUNA,  RP.
DENTAL X-RAY E.U.
ENVIGADO ANTIOQUIA,  CO.
Manufacturer;  
DENTAL X-RAY E.U.
ENVIGADO ANTIOQUIA,  CO.
DENTAL/MEDICAL OPTICS MFG., INC.
ISLAND PARK,  NY,  US.
Manufacturer;  
DENTAL/MEDICAL OPTICS MFG., INC.
ISLAND PARK,  NY ,  US.
DENTALAIRE PRODUCTS INTERNATIONAL
FOUNTAIN VALLEY,  CA,  US.
Specification Developer;   Repackager/Relabeller;  
DENTALAIRE PRODUCTS INTERNATIONAL
FOUNTAIN VALLEY,  CA ,  US.
DENTALEYE AB
SPANGA,  SW.
Manufacturer;  
DENTALEYE AB
SPANGA,  SW.
DENTALEZ GROUP
LANCASTER,  PA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTALEZ, INC.
MALVERN,  PA ,  US.
DENTALEZ GROUP
MALVERN,  PA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
DENTALEZ, INC.
MALVERN,  PA ,  US.
DENTALEZ OF ALABAMA
BAY MINETTE,  AL,  US.
Manufacturer;  
DENTALEZ, INC.
MALVERN,  PA ,  US.
DENTALFILM, S.R.L.
SETTIMO TORINESE,  IT.
Manufacturer;  
DENTALFILM, S.R.L.
SETTIMO TORINESE,  IT.
DENTALGESIA SYSTEMS
PROVIDENCE,  RI,  US.

DENTALGESIA SYSTEMS
PROVIDENCE,  RI ,  US.
DENTALIUM DENTAL CERAMICS, INC.
NEWPORT BEACH,  CA,  US.
Initial Importer;   Specification Developer;  
DENTALIUM DENTAL CERAMICS, INC.
NEWPORT BEACH,  CA ,  US.
DENT-ALL CORP.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
DENT-ALL CORP.
MIAMI,  FL ,  US.
DENTALSAFE SYSTEMS PTY., LTD.
WATERLOO, SYDNEY, NSW,  AS.
Specification Developer;  
DENTALSAFE SYSTEMS PTY., LTD.
KINGSFORD, SYDNEY, NSW,  AS.
DENTAL-VERTRIEB THOMAS SCHROER
PILOTYSTRABE 1,  GM.
Unregistered Foreign Lister;  
DENTAL-VERTRIEB THOMAS SCHROER
PILOTYSTRABE 1,  GM.
DENTALVIEW
LAKE FOREST,  CA,  US.
Specification Developer;  
DENTALVIEW
LAKE FOREST,  CA ,  US.
DENTAMAX, INC.
VANCOUVER,  WA,  US.
Initial Importer;  
DENTAMAX, INC.
VANCOUVER,  WA ,  US.
DENTAMERICA
INDUSTRY,  CA,  US.
Repackager/Relabeller;  
DENTAMERICA
INDUSTRY,  CA ,  US.
DENTANURSE (UK) LTD.
HEREFORD, HEREFORDSHIRE,  UK.
Manufacturer;  
DENTANURSE (UK) LTD.
HEREFORD, HEREFORDSHIRE,  UK.
DENTAPREG USA, INC.
LANCASTER,  NY,  US.
Initial Importer;  
ADVANCED DENTAL MATERIALS, A.S.
EZ.
DENTATUS AB
HAGERSTEN,  SW.
Manufacturer;  
DENTATUS AB
HAGERSTEN,  SW.
DENTATUS USA, LTD.
NEW YORK,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
DENTATUS USA, LTD.
NEW YORK,  NY ,  US.
DENTAURUM
NEWTOWN,  PA,  US.
Initial Importer;  
J.P. WINKELSTROETER KG
ISPRINGEN,  GM.
DENTAURUM J.P. WINKELSTROETER KG
ISPRINGEN,  GM.
Manufacturer;  
J.P. WINKELSTROETER KG
ISPRINGEN,  GM.
DENTCO, INC.
HUMACAO,  PR,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
SMITHKLINE BEECHAM CONSUMER HEALTHCARE, L.P.
PITTSBURG,  PA ,  US.
DENTEC CO., INC.
MAHWAH,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
DENTEC CO., INC.
MAHWAH,  NJ ,  US.
DENTECH
SAN DIEGO,  CA,  US.
Initial Importer;  
DENTECH
SAN DIEGO,  CA ,  US.
DENTECH CORP.
TOKYO,  JA.
Manufacturer;  
DENTECH CORP.
TOKYO,  JA.
DENTECH CORP.
LYNDEN,  WA,  US.
Initial Importer;   Manufacturer;  
DENTECH CORP.
LYNDEN,  WA ,  US.
DENTECH PRODUCTS
LANGLEY, B.C.,  CA.
Manufacturer;  
ASH TEMPLE LTD.
VAUGHAN, ONTARIO,  CA.
DENTECO, INC.
WORCESTER,  MA,  US.
Repackager/Relabeller;  
DENTECO, INC.
WORCESTER,  MA ,  US.
DENTECON, INC.
LOS ANGELES,  CA,  US.
Manufacturer;  
DENTECON, INC.
LOS ANGELES,  CA ,  US.
DENTEK INTERNATIONAL, L.L.C.
SHORT HILLS,  NJ,  US.
Initial Importer;  
DENTEK INTERNATIONAL, L.L.C.
SHORT HILLS,  NJ ,  US.
DENTEK ORAL CARE, INC.
MARYVILLE,  TN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTEK ORAL CARE, INC.
MARYVILLE,  TN ,  US.
DENTEVITA LAB.
ADELAIDE, S.A.,  AS.
Manufacturer;  
DENTEVITA LAB.
ADELAIDE, S.A.,  AS.
DENTEX DENTAL INDUSTRIAL CORP.
TAIPEI,  TW.
Manufacturer;  
DENTEX DENTAL INDUSTRIAL CORP.
TAIPEI,  TW.
DENTEXX/FIRST MEDICA INFECTION CONTROL ASSOC.
GREENSBORO,  NC,  US.
Initial Importer;  
DENTEXX/FIRST MEDICA INFECTION CONTROL ASSOC.
GREENSBORO,  NC ,  US.

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Last Modified: 29 April 2006
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