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510(k) K191720

BRUIS Software Suite by Mechanodontics, Inc. — Product Code PNN

K191720 is an FDA 510(k) premarket notification submitted by Mechanodontics, Inc. for the device "BRUIS Software Suite". The FDA issued a decision of Substantially Equivalent on Apr 17, 2020. 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
Apr 17, 2020
Date Received
Jun 27, 2019
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
510(k)

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.

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  • K253343 — Celebrace Software (Dec 29, 2025)
  • K250198 — Laon Ortho (Apr 23, 2025)
  • K241153 — Progressive Orthodontics App (Oct 11, 2024)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232564 — Align Studio (Mar 12, 2024)
  • K233616 — Clevaligner Software (V1.0.0) (Jan 11, 2024)
  • K232549 — NemoCast (Nov 21, 2023)

FDA data resources