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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 K920781
Device Name FLASH BOND
Applicant
Advanced Orthodontics Systems, Inc.
2346 Flatbush Ave.
Brooklyn,  NY  11234
Applicant Contact LAWRENCE HERMANN
Correspondent
Advanced Orthodontics Systems, Inc.
2346 Flatbush Ave.
Brooklyn,  NY  11234
Correspondent Contact LAWRENCE HERMANN
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/20/1992
Decision Date 04/21/1992
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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