Cleared Traditional

K041718 - KELES FACEMASK

K041718 is an FDA 510(k) clearance for KELES FACEMASK, manufactured by Great Lakes Orthodontics, Ltd.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K041718 · Great Lakes Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
113d
Days
Class 2
Risk

K041718 is an FDA 510(k) clearance for the KELES FACEMASK. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on October 15, 2004 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - 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 Great Lakes Orthodontics, Ltd. devices

FDA 510(k) Submission Details - K041718

510(k) Number K041718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2004
Decision Date October 15, 2004
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZB Device Classification - Class 2, Special Controls

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZB Headgear, Extraoral, Orthodontic

All 10
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K041718.
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K936151 · Dentauraum, Inc. · Aug 1994