Cleared Traditional

K030072 - EVERSTICK PERIO

K030072 is an FDA 510(k) clearance for EVERSTICK PERIO, 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 92-day FDA review.

K030072 · Stick Tech , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
92d
Days
Class 2
Risk

K030072 is an FDA 510(k) clearance for the EVERSTICK PERIO. 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 April 10, 2003 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 872.3760 - 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: 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 - K030072

510(k) Number K030072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2003
Decision Date April 10, 2003
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 210
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K030072.
CARBON FIBER BRIDGE, MODEL 28757
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UFI GEL HARD C
K030916 · Voco GmbH · Jun 2003
TOKUYAMA SOFRELINER TOUGH
K030663 · Tokuyama Dental Corporation · May 2003
TOKUYAMA REBASE II
K022641 · Tokuyama America, Inc. · Oct 2002
SECURE SOFT
K021437 · Imtec Corp. · Jul 2002
SECURE RELINE/PICKUP MATERIAL
K021586 · Imtec Corp. · Jun 2002