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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Zinc Oxide Eugenol
510(k) Number K161630
Device Name Provicol QM Plus
Applicant
VOCO GMBH
ANTON-FLETTNER-STR. 1-3
CUXHAVEN,  DE 27472
Applicant Contact TH. PLAUMANN
Correspondent
VOCO GMBH
ANTON-FLETTNER-STR. 1-3
CUXHAVEN,  DE 27472
Correspondent Contact T. GERKENSMEIER
Regulation Number872.3275
Classification Product Code
EMB  
Date Received06/13/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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