FDA 510(k) Applications for Medical Device:
Dam, Rubber

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K050318 BIOENVELOP AGRO, INC. 1129 BLOOMFIELD AVENUE
WEST CALDWELL NJ 07006
K010935 BRITESMILE, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K040797 BRITESMILE, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K151945 DENALI CORPORATION 134 OLD WASHINGTON STREET
HANOVER MA 02339
K043301 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K972775 INTERDENT, INC. 2230 SOUTH BARRINGTON
LOS ANGELES CA 90064
K983227 KREATIV, INC. 9025 BALBOA AVE.
SAN DIEGO CA 92123
K182118 Mavrik Dental Systems Ltd 25 Ha Haroshet Street, 6th floor
Raanana
K021524 PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE.
CHICAGO IL 60618
K022522 PULPDENT CORPORATION 80 OAKLAND ST.
WATERTOWN MA 02472
K021613 SHOFU DENTAL CORP. 1225 STONE DR.
SAN MARCOS CA 92078
K954990 THE HYGENIC CORP. 1245 HOME AVE.
AKRON OH 44310
K961472 WORLDWIDE DENTAL, INC. 100 MAIN ST.
CONCORD MA 01742




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