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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 K122748
Device Name ENGLER 25K SERIES ULTRASONIC INSERTS
Original Applicant
ENGLER ENGINEERING CORP.
1099 east 47th st.
hialeah,  FL  33013
Original Contact joel katz
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/14/2012
Decision Date 06/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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