Cleared Traditional

Qraycam PRO

K221275 · AIOBIO Co., Ltd. · Dental
Sep 2024
Decision
856d
Days
Class 2
Risk

About This 510(k) Submission

K221275 is an FDA 510(k) clearance for the Qraycam PRO, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by AIOBIO Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 4, 2024, 856 days after receiving the submission on May 2, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K221275 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2022
Decision Date September 04, 2024
Days to Decision 856 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NBL — Laser, Fluorescence Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745