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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 K122501
Device Name AEI DR. TERAUCHI ULTRASONIC TIPS
Applicant
AMERICAN EAGLE INSTRUMENTS, INC.
6575 BUTLER CREEK ROAD
MISSOULA,  MT  59808
Applicant Contact KRISTEN SCHALLIOL
Correspondent
AMERICAN EAGLE INSTRUMENTS, INC.
6575 BUTLER CREEK ROAD
MISSOULA,  MT  59808
Correspondent Contact KRISTEN SCHALLIOL
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/16/2012
Decision Date 03/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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