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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eraser, Dental Stain
510(k) Number K891338
Device Name SMYLON (DENTAL STAIN ERASER)
Applicant
The Smylon Co.
7366 Waring Ave.
Los Angeles,  CA  90046
Applicant Contact FRANK COPPOLA
Correspondent
The Smylon Co.
7366 Waring Ave.
Los Angeles,  CA  90046
Correspondent Contact FRANK COPPOLA
Regulation Number872.6855
Classification Product Code
MAU  
Date Received03/13/1989
Decision Date 11/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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