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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K882821
Device Name VITRABOND LIGHT CURE GLASS IONOMER LINER
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact SCOTT T ERICKSON
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact SCOTT T ERICKSON
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received07/08/1988
Decision Date 09/15/1988
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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