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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 K893255
Device Name SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
Applicant
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Applicant Contact PAUL RIDDLE
Correspondent
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Correspondent Contact PAUL RIDDLE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received04/28/1989
Decision Date 06/21/1989
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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