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510(k) K203442

Inbrace Orthodontic System by Swift Health Systems, Inc. — Product Code PNN

K203442 is an FDA 510(k) premarket notification submitted by Swift Health Systems, Inc. for the device "Inbrace Orthodontic System". The FDA issued a decision of Substantially Equivalent on February 19, 2021. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2021
Date Received
November 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthodontic Software
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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.

Other clearances for product code PNN

  • K260419 — LingOral Dental Design System (May 8, 2026)
  • K253565 — SureSmile Software (March 4, 2026)
  • K252507 — SmileInspector (January 7, 2026)
  • K253343 — Celebrace Software (December 29, 2025)
  • K250198 — Laon Ortho (April 23, 2025)
  • K241153 — Progressive Orthodontics App (October 11, 2024)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232564 — Align Studio (March 12, 2024)
  • K233616 — Clevaligner Software (V1.0.0) (January 11, 2024)
  • K232549 — NemoCast (November 21, 2023)

FDA data resources