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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coating, filling material, resin
510(k) Number K862590
Device Name 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
Applicant
3M COMPANY
chemolite blvd. & washington
city rd. 19
cottae grove,  MN  55016
Applicant Contact don h mckenzie
Correspondent
3M COMPANY
chemolite blvd. & washington
city rd. 19
cottae grove,  MN  55016
Correspodent Contact don h mckenzie
Regulation Number872.3310
Classification Product Code
EBD  
Date Received07/07/1986
Decision Date 07/22/1986
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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