Cleared Traditional

Inbrace Orthodontic System (K203442) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203442 · Swift Health Systems, Inc. · Dental device
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Feb 2021
Decision
88d
Days
Class 2
Risk

K203442 is an FDA 510(k) clearance for the Inbrace Orthodontic System. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Swift Health Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 2021 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Swift Health Systems, Inc. devices

Submission Details

510(k) Number K203442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2020
Decision Date February 19, 2021
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNN Orthodontic Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PNN Orthodontic Software

All 30
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K203442.
Vision
K212770 · Softsmile, Inc. · Dec 2021
ArchForm Orthodontic Software System
K213916 · Archform, Inc. · Dec 2021
BRIUS Planner Software
K212828 · Brius Technologies, Inc. · Oct 2021
PlaniMax Orthodontic Software
K201036 · Choice Biotech, Inc. · Dec 2020
AUTOLIGN
K192847 · Diorco Co., Ltd. · Jul 2020
ULab Systems uDesign Software
K200772 · Ulab Systems, Inc. · Jun 2020