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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 K901488
Device Name LYNX-SM, SCLAER DENTAL HANDPIECE
Applicant
Mti Precision Products
P.O. Box 221
175 Oberlin N. Ave.
Lakewood,  NJ  08701
Applicant Contact MICHAEL FELDMAN
Correspondent
Mti Precision Products
P.O. Box 221
175 Oberlin N. Ave.
Lakewood,  NJ  08701
Correspondent Contact MICHAEL FELDMAN
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/29/1990
Decision Date 05/15/1990
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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