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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K123876
Device Name SYNERGY
Applicant
Odontit S.A.
2600 Mullinix Mill Rd.
Mt. Airy,  MD  21771
Applicant Contact BLIX WINSTON
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.3930
Classification Product Code
NPM  
Date Received12/17/2012
Decision Date 05/22/2014
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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