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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K183542
Device Name Signature Orthodontic System
Applicant
Signature Orthodontics
1035 Cambridge St., Suite 14a
Cambridge,  MA  02141
Applicant Contact Alfred Charles Griffin
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number872.5470
Classification Product Code
NJM  
Date Received12/20/2018
Decision Date 01/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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