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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K935150
Device Name SONIPLAK
Applicant
American Dentronics, Inc.
1350 E. Flamingo Rd., #573
Las Vegas,  NV  89119
Applicant Contact RONALD K MURAYAMA
Correspondent
American Dentronics, Inc.
1350 E. Flamingo Rd., #573
Las Vegas,  NV  89119
Correspondent Contact RONALD K MURAYAMA
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received10/28/1993
Decision Date 05/18/1994
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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