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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 K083059
Device Name AIR SONIC SCALER
Applicant
Dpm USA Corp.
1460 NW 107 Ave. Suite G
Miami,  FL  33172
Applicant Contact GEORGE ECHEVERRI
Correspondent
Dpm USA Corp.
1460 NW 107 Ave. Suite G
Miami,  FL  33172
Correspondent Contact GEORGE ECHEVERRI
Regulation Number872.4850
Classification Product Code
ELC  
Date Received10/14/2008
Decision Date 01/30/2009
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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