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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 K863676
Device Name GENTEEL
Applicant
Luben Dental Co., Inc.
521 Fifth Ave., Suite 1740
New York,  NY  10175
Applicant Contact STANSORD MARLEY
Correspondent
Luben Dental Co., Inc.
521 Fifth Ave., Suite 1740
New York,  NY  10175
Correspondent Contact STANSORD MARLEY
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/19/1986
Decision Date 10/02/1986
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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