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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 K843527
Device Name ORTHOMITE 111 ADHESIVE
Applicant
Rocky Mountain Orthodontics, Inc.
P.O. Box 17085
Denver,  CO  80217
Applicant Contact KEVIN R COOK
Correspondent
Rocky Mountain Orthodontics, Inc.
P.O. Box 17085
Denver,  CO  80217
Correspondent Contact KEVIN R COOK
Regulation Number872.3750
Classification Product Code
DYH  
Date Received09/07/1984
Decision Date 10/18/1984
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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