Cleared Traditional

K040117 - UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT

K040117 is an FDA 510(k) clearance for UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT, manufactured by Arrow Industries, LLC. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K040117 · Arrow Industries, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
92d
Days
Class 1
Risk

K040117 is an FDA 510(k) clearance for the UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Arrow Industries, LLC (Neche, US). The FDA issued a Cleared decision on April 21, 2004 after a review of 92 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.

FDA 510(k) Submission Details - K040117

510(k) Number K040117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date April 21, 2004
Days to Decision 92 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
36d faster than avg
Panel avg: 128d · This submission: 92d
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 277
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K040117.
MICROSCOPE SYSTEM
K041805 · Miras Mirror Imaging Solutions, Ltd. · Sep 2004
MARE DENTAL OPERATIVE UNIT
K041458 · Denimed Electronica S.H. · Aug 2004
COCOON HYGIENIST
K040529 · Satelec · Aug 2004
HAWK INTRAORAL CAMERA AND ACCESSORIES
K040116 · Dxm Co., Ltd. · Apr 2004
BIOFREE
K033925 · Dental Components, Inc. · Apr 2004
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
K040691 · Win-Us Technology Co., Ltd. · Mar 2004
K040117 · UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
Download PDF FDA Summary Arrow Industries, LLC