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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 K864996
Device Name ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
Applicant
Dentsply Intl.
Cavitron Products
11-40 Borden Ave.
Long Island City,  NY  11101
Applicant Contact HAROLD L BRINKMAN
Correspondent
Dentsply Intl.
Cavitron Products
11-40 Borden Ave.
Long Island City,  NY  11101
Correspondent Contact HAROLD L BRINKMAN
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/22/1986
Decision Date 02/19/1987
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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