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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prophy Powder, Airbrush Accessory
510(k) Number K151748
Device Name Clean & More
Applicant
3M Deutschland GmbH
Espe Platz
Seefeld,  DE 82234
Applicant Contact DESI W SOEGIARTO
Correspondent
3M Deutschland GmbH
Espe Platz
Seefeld,  DE 82234
Correspondent Contact DESI W SOEGIARTO
Regulation Number872.6080
Classification Product Code
PIP  
Date Received06/29/2015
Decision Date 03/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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