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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 K232827
Device Name LightForce Orthodontic System
Applicant
Lightforce Orthodontics
44 Third Ave.
Burlington,  MA  01803
Applicant Contact Jeffrey Roberts
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
NJM  
Subsequent Product Code
PNN  
Date Received09/13/2023
Decision Date 09/14/2023
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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