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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 K200148
Device Name LightForce Orthodontic System (LFO System)
Applicant
LightForce Orthodontics
1035 Cambridge Street, Suite 14a
Cambridge,  MA  02141
Applicant Contact Amos N Benninga
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
NJM  
Date Received01/22/2020
Decision Date 02/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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