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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K000848
Device Name TDK HANDPIECES
Applicant
Orasystems
555 Passaic Ave.
West Caldwell,  NJ  07006
Applicant Contact BERNARD SESSMAN
Correspondent
Orasystems
555 Passaic Ave.
West Caldwell,  NJ  07006
Correspondent Contact BERNARD SESSMAN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/15/2000
Decision Date 10/05/2000
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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