Home / 510(k) Clearances / K250753

510(k) K250753

VELMENI for DENTISTS (V4D) by Velmeni, Inc. — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2025
Date Received
March 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Medical Image
Device Class
Class II
Regulation Number
892.2070
Review Panel
RA
Submission Type

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

Other clearances by Velmeni, Inc.

  • K240003 — Velmeni for Dentists (V4D) (August 30, 2024)

Other clearances for product code MYN

  • K251934 — qXR-Detect (January 16, 2026)
  • K252934 — Diagnocat (January 15, 2026)
  • K253009 — DS Core Detect (January 7, 2026)
  • K252086 — DTX Studio Assist (November 17, 2025)
  • K250525 — Second Opinion® Panoramic (November 14, 2025)
  • K250264 — SugarBug (1.x) (November 7, 2025)
  • K251002 — Videa Dental AI (September 19, 2025)
  • K243234 — Second Opinion® CS (June 12, 2025)
  • K242437 — Smile Dx® (May 14, 2025)
  • K243893 — Second Opinion® Pediatric (May 5, 2025)