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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K894061
Device Name STUDIO UNO
Applicant
Eurodent, Inc.
1381, Rue Ampere
Boucherville, Quebec
Canada J4b 5z5,  CA
Applicant Contact ALDO MARUCCHI-FOINO
Correspondent
Eurodent, Inc.
1381, Rue Ampere
Boucherville, Quebec
Canada J4b 5z5,  CA
Correspondent Contact ALDO MARUCCHI-FOINO
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/07/1989
Decision Date 11/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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