Cleared Traditional

K183121 - Qraypen (FDA 510(k) Clearance)

Class I Dental device.

K183121 · AIOBIO Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
251d
Days
Class 1
Risk

K183121 is an FDA 510(k) clearance for the Qraypen. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by AIOBIO Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 18, 2019 after a review of 251 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all AIOBIO Co., Ltd. devices

Submission Details

510(k) Number K183121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2018
Decision Date July 18, 2019
Days to Decision 251 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 127d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

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