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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K954820
Device Name SCALEX 800
Applicant
Dentamerica
P.O. Box 3200
Industry,  CA  91744
Applicant Contact JERRY HUANG
Correspondent
Dentamerica
P.O. Box 3200
Industry,  CA  91744
Correspondent Contact JERRY HUANG
Regulation Number872.4850
Classification Product Code
ELC  
Date Received10/20/1995
Decision Date 01/18/1996
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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