FDA 510(k)

Inbrace Orthodontic System

K-Number: K203442 · 2021-02-19

Decision Date2021-02-19

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Inbrace Orthodontic System is the device name listed in this FDA 510(k) record. The listed applicant is Swift Health Systems, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K203442. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inbrace Orthodontic System?

Inbrace Orthodontic System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Swift Health Systems, Inc.. The 510(k) number is K203442.

When did Inbrace Orthodontic System receive FDA 510(k) clearance?

Inbrace Orthodontic System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K203442.

Who is the listed applicant for Inbrace Orthodontic System?

The FDA 510(k) record lists Swift Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inbrace Orthodontic System?

The FDA product code for Inbrace Orthodontic System is PNN.

Related Devices (Code: PNN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLC K253343Celebrace SoftwareCelebrace K250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.