LightForce Orthodontic System

Bracket, Ceramic, Orthodontic

LightForce Orthodontics

The following data is part of a premarket notification filed by Lightforce Orthodontics with the FDA for Lightforce Orthodontic System.

Pre-market Notification Details

Device IDK222764
510k NumberK222764
Device Name:LightForce Orthodontic System
ClassificationBracket, Ceramic, Orthodontic
Applicant LightForce Orthodontics 44 Third Ave Burlington,  MA  01803
ContactKelsey Fafara
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-09-13
Decision Date2022-09-14

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