Cleared Traditional

K040116 - HAWK INTRAORAL CAMERA AND ACCESSORIES

K040116 is an FDA 510(k) clearance for HAWK INTRAORAL CAMERA AND ACCESSORIES, manufactured by Dxm Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K040116 · Dxm Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
91d
Days
Class 1
Risk

K040116 is an FDA 510(k) clearance for the HAWK INTRAORAL CAMERA AND ACCESSORIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dxm Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on April 20, 2004 after a review of 91 days - within the typical 510(k) review window.

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 Dxm Co., Ltd. devices

FDA 510(k) Submission Details - K040116

510(k) Number K040116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date April 20, 2004
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EIA Unit, Operative Dental

All 172
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