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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 K140684
Device Name CLINPRO PROPHY POWDER
Applicant
3M Deutschland GmbH
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact DESI W SOEGIARTO
Correspondent
3M Deutschland GmbH
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact DESI W SOEGIARTO
Regulation Number872.6080
Classification Product Code
PIP  
Date Received03/18/2014
Decision Date 10/24/2014
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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