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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 -1000
Applicant Contact SCOTT T ERICKSON
Correspondent
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
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
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