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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K904090
Device Name ORTHODONTIC BONDING ADHESIVE CONTROL
Applicant
Lancer Orthodontics, Inc.
6050 Avenida Encinas
P.O. Box 819
Carlsbad,  CA  92008
Applicant Contact MIKE EKINAKA
Correspondent
Lancer Orthodontics, Inc.
6050 Avenida Encinas
P.O. Box 819
Carlsbad,  CA  92008
Correspondent Contact MIKE EKINAKA
Regulation Number872.3750
Classification Product Code
DYH  
Date Received09/06/1990
Decision Date 04/29/1991
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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