Cleared Traditional

K040691 - INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D

K040691 is an FDA 510(k) clearance for INTRA ORAL CAMERA SYSTEM & ACCESSORIES, manufactured by Win-Us Technology Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K040691 · Win-Us Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
6d
Days
Class 1
Risk

K040691 is an FDA 510(k) clearance for the INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Win-Us Technology Co., Ltd. (Alpharetta, US). The FDA issued a Cleared decision on March 23, 2004 after a review of 6 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040691

510(k) Number K040691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date March 23, 2004
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 128d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Intertek Testing Services

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.

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 K040691.
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
K040117 · Arrow Industries, LLC · Apr 2004
HAWK INTRAORAL CAMERA AND ACCESSORIES
K040116 · Dxm Co., Ltd. · Apr 2004
BIOFREE
K033925 · Dental Components, Inc. · Apr 2004
STV PRO 2
K033419 · Trophy Radiologie · Feb 2004
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
K032757 · A-Dec, Inc. · Dec 2003
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
K032756 · A-Dec, Inc. · Dec 2003
K040691 · INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
Download PDF FDA Summary Win-Us Technology Co.…