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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 K923399
Device Name CHALLENGE II - PASTE ADHESIVE
Applicant
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact LARRY WILLS
Correspondent
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact LARRY WILLS
Regulation Number872.3750
Classification Product Code
DYH  
Date Received07/10/1992
Decision Date 10/27/1992
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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