Inbrace Orthodontic System

Orthodontic Software

Swift Health Systems, Inc.

The following data is part of a premarket notification filed by Swift Health Systems, Inc. with the FDA for Inbrace Orthodontic System.

Pre-market Notification Details

Device IDK203442
510k NumberK203442
Device Name:Inbrace Orthodontic System
ClassificationOrthodontic Software
Applicant Swift Health Systems, Inc. 111 Academy, Suite 150 Irvine,  CA  92617
ContactAlicia Mszyca
CorrespondentAlicia Mszyca
Swift Health Systems, Inc. 111 Academy, Suite 150 Irvine,  CA  92617
Product CodePNN  
Subsequent Product CodeDZC
Subsequent Product CodeEJF
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-02-19

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