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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K123697
Device Name MATRICEL DENTAL BARRIER MEMBRANE
Applicant
Matricel GmbH
Kaiserstrabe 100
Herzogenrath,  DE 52134
Applicant Contact DR. INGO HESCHEL
Correspondent
Matricel GmbH
Kaiserstrabe 100
Herzogenrath,  DE 52134
Correspondent Contact DR. INGO HESCHEL
Regulation Number872.3930
Classification Product Code
NPL  
Date Received12/03/2012
Decision Date 02/24/2014
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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