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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K073395
Device Name GILB-2, GLASS IONOMER PROTECTIVE COATING
Applicant
3M Espe Dental Products
3m Center; Bldg. 260-2a-11
St. Paul,  MN  55144 -1000
Applicant Contact KAREN O'MALLEY
Correspondent
3M Espe Dental Products
3m Center; Bldg. 260-2a-11
St. Paul,  MN  55144 -1000
Correspondent Contact KAREN O'MALLEY
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Codes
EBC   EJK   LBH  
Date Received12/03/2007
Decision Date 01/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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