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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 K123139
Device Name ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
Applicant
Asi Medical, Inc.
14550 E Easter Ave.
Suite 700
Centennial,  CO  80112
Applicant Contact JOHN MCPEEK
Correspondent
Asi Medical, Inc.
14550 E Easter Ave.
Suite 700
Centennial,  CO  80112
Correspondent Contact JOHN MCPEEK
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Codes
DZI   EBZ   EFA   EIA   EKR  
EKX   LQY  
Date Received10/05/2012
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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