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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 K182778
Device Name LC GLOSSFILL XR
Applicant
S&C Polymer Silicon- Und Composite Spezialitaeten GmbH
Robert-Bosch-Str. 2
Elmshorn,  DE 25335
Applicant Contact Christian Boettcher
Correspondent
S&C Polymer Silicon- Und Composite Spezialitaeten GmbH
Robert-Bosch-Str. 2
Elmshorn,  DE 25335
Correspondent Contact Christian Boettcher
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/01/2018
Decision Date 04/22/2019
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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