Cleared Traditional

K021126 - EVERSTICK ORTHO

K021126 is an FDA 510(k) clearance for EVERSTICK ORTHO, manufactured by Stick Tech , Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K021126 · Stick Tech , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
35d
Days
Class 2
Risk

K021126 is an FDA 510(k) clearance for the EVERSTICK ORTHO. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Stick Tech , Ltd. (Mount Vernon, US). The FDA issued a Cleared decision on May 13, 2002 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 - K021126

510(k) Number K021126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2002
Decision Date May 13, 2002
Days to Decision 35 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
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 320
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K021126.
SECURE SOFT
K021437 · Imtec Corp. · Jul 2002
SECURE RELINE/PICKUP MATERIAL
K021586 · Imtec Corp. · Jun 2002
AROMACRYL
K021121 · Aromacryl, LLC · May 2002
RIBBOND - TRIAXIAL
K013881 · Ribbond, Inc. · Jan 2002
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
K012882 · Thermoelastic Technologies, Inc. · Nov 2001
EVERSTICK
K011788 · Stick Tech , Ltd. · Nov 2001
K021126 · EVERSTICK ORTHO
Download PDF FDA Summary Stick Tech , Ltd.