510(k) K233625

RAYDENT SW by Ray Co., Ltd. — Product Code PNN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 16, 2024
Date Received: November 13, 2023
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 by Ray Co., Ltd.

K251798 — RCT700 (November 25, 2025)
K251109 — SMARTDent (May 21, 2025)
K243903 — RCT600 (March 12, 2025)
K232325 — RAYSCAN a-Expert (April 18, 2024)
K232287 — RAYSCAN a-Expert3D (August 31, 2023)
K230753 — RCT800 (April 11, 2023)
K213226 — RCT700 (November 29, 2021)
K211105 — Ear-Friendly Mask (May 17, 2021)
K192737 — RCT800 (October 22, 2019)
K190812 — RAYSCAN a-Expert3D (April 24, 2019)

Other clearances for product code PNN

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)
K232564 — Align Studio (March 12, 2024)
K233616 — Clevaligner Software (V1.0.0) (January 11, 2024)
K232549 — NemoCast (November 21, 2023)
K232429 — Titan Dental Design (October 13, 2023)
K223518 — iOrtho (June 13, 2023)