Cleared Traditional

SMARTDent

K251109 · Ray Co., Ltd. · Radiology
May 2025
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K251109 is an FDA 510(k) clearance for the SMARTDent, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Ray Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on May 21, 2025, 40 days after receiving the submission on April 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251109 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date May 21, 2025
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050