Cleared Traditional

K040116 - HAWK INTRAORAL CAMERA AND ACCESSORIES

K040116 is the FDA 510(k) clearance for HAWK INTRAORAL CAMERA AND ACCESSORIES by Dxm Co., Ltd.. It is a Class 1 Dental device (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

Submission Details

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.

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.

Regulatory Peers - EIA Unit, Operative Dental

All 61
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