Cleared Traditional

K221275 - Qraycam PRO (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K221275 is an FDA 510(k) clearance for the Qraycam PRO. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by AIOBIO Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 4, 2024 after a review of 856 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all AIOBIO Co., Ltd. devices

Submission Details

510(k) Number K221275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
729d slower than avg
Panel avg: 127d · This submission: 856d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBL Laser, Fluorescence Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

KMC, Inc.
JeongKeun Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.