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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Remover, Crown
510(k) Number K951299
Device Name EASY PNEUMATIC CROWN AND BRIDGE REMOVER
Applicant
Dentco, Inc.
5 Franklin Ave.
White Plains,  NY  10601
Applicant Contact PATRICK J LAMB
Correspondent
Dentco, Inc.
5 Franklin Ave.
White Plains,  NY  10601
Correspondent Contact PATRICK J LAMB
Regulation Number872.4565
Classification Product Code
EIS  
Date Received03/22/1995
Decision Date 08/29/1995
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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