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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression Tray, Resin
510(k) Number K850014
Device Name HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE
Applicant
Medi-Dent American, Inc.
110 24th St.
Niagara Falls,  NY  14303
Applicant Contact JOHN R MINICUCCI
Correspondent
Medi-Dent American, Inc.
110 24th St.
Niagara Falls,  NY  14303
Correspondent Contact JOHN R MINICUCCI
Regulation Number872.3670
Classification Product Code
EBH  
Date Received01/02/1985
Decision Date 01/23/1985
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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