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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K183337
Device Name LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
Applicant
DMG Chemisch-Pharmazeutische Fabrik GmbH
Elbgaustrasse 248
Hamburg,  DE 22547
Applicant Contact Sonja Toeppen
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
POW  
Date Received12/03/2018
Decision Date 05/29/2019
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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