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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 K173124
Device Name PEEK Biosolution
Applicant
Merz Dental GmbH
Eetzweg 20
Lutjenburg,  DE D-24321
Applicant Contact Claudia Bobrowski
Correspondent
Washington Regulatory Consultants, LLC
5616 Mariola Pi NE
Albuquerque,  MN  87111
Correspondent Contact Richard G. Hunter
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/29/2017
Decision Date 12/18/2017
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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