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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 K941392
Device Name JET UNIT (CJ HANDPIECE)
Applicant
Dentsply Intl.
500 W. College Ave.
York,  PA  17404
Applicant Contact JEFFERY P LEHN
Correspondent
Dentsply Intl.
500 W. College Ave.
York,  PA  17404
Correspondent Contact JEFFERY P LEHN
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/22/1994
Decision Date 05/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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