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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K895401
Device Name NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM
Applicant
Rocky Mountain Orthodontics, Inc.
P.O. Box 17085
Denver,  CO  80217
Applicant Contact DARRELL PARKER
Correspondent
Rocky Mountain Orthodontics, Inc.
P.O. Box 17085
Denver,  CO  80217
Correspondent Contact DARRELL PARKER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/07/1989
Decision Date 12/04/1989
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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