Home / 510(k) Clearances / K182206

510(k) K182206

RiX70 DC by Trident S.R.L — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2018
Date Received
August 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Trident S.R.L

  • K222666 — X-View 3D Pan/X-View 2D Pan (July 10, 2023)
  • K200625 — I-View Gold and Imagen Gold Dental Sensors (April 15, 2020)
  • K162619 — I View and Imagen Sensor (November 4, 2016)
  • K160386 — ReadeR, VieweR, QuickScan PSP (March 10, 2016)

Other clearances for product code EHD

  • K253864 — NOMAD Pro 3 (March 20, 2026)
  • K252110 — Dental X-RAY Unit (AJX200) (March 12, 2026)
  • K254018 — Portable Dental X-ray Device (GT-1) (February 19, 2026)
  • K252909 — Diagnostic X-Ray Equipment Model POCT22 (February 3, 2026)
  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K242185 — Rextar Pro (December 4, 2024)
  • K242591 — XERO-alpha (November 1, 2024)
  • K241963 — WERAY (July 30, 2024)
  • K241305 — LifeRay Intraoral Handheld X-ray System (July 5, 2024)
  • K240759 — REMEX-GR100 (May 13, 2024)