Cleared Traditional

K051953 - EVERSTICK A&O

K051953 is an FDA 510(k) clearance for EVERSTICK A&O, manufactured by Stick Tech , Ltd.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K051953 · Stick Tech , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
246d
Days
Class 2
Risk

K051953 is an FDA 510(k) clearance for the EVERSTICK A&O. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Stick Tech , Ltd. (Mount Vernon, US). The FDA issued a Cleared decision on March 21, 2006 after a review of 246 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Stick Tech , Ltd. devices

FDA 510(k) Submission Details - K051953

510(k) Number K051953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date March 21, 2006
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYW Device Classification - Class 2, Special Controls

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
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 - DYW Bracket, Plastic, Orthodontic

All 27
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K051953.
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K050730 · Ultradent Products, Inc. · Mar 2005