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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 K920425
Device Name 3M BRAND RESTORATIVE Z100
Applicant
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144
Applicant Contact SCOTT T ERICKSON
Correspondent
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144
Correspondent Contact SCOTT T ERICKSON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/03/1992
Decision Date 03/20/1992
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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