Cleared Traditional

RAYDENT SW

K233625 · Ray Co., Ltd. · Dental
May 2024
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K233625 is an FDA 510(k) clearance for the RAYDENT SW, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by Ray Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on May 16, 2024, 185 days after receiving the submission on November 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K233625 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2023
Decision Date May 16, 2024
Days to Decision 185 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PNN — Orthodontic Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition 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.