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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 K213343
Device Name Saremco Print CROWNTEC
Applicant
Saremco Dental AG
Gewerbestrasse 4
Rebstein,  CH CH-9445
Applicant Contact Franca Schmid
Correspondent
Bqc Consulting, LLC
24341 Barbados Dr.
Dana Point,  CA  92629
Correspondent Contact Nevine Erian
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBG   PZY  
Date Received10/07/2021
Decision Date 01/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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