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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
Applicant
Engler Engineering Corp.
1099 E. 47th St.
Hialeah,  FL  33013
Applicant Contact JOEL KATZ
Correspondent
Engler Engineering Corp.
1099 E. 47th St.
Hialeah,  FL  33013
Correspondent Contact JOEL KATZ
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/07/2012
Decision Date 06/11/2013
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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