Cleared Traditional

K093059 - SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT

K093059 is an FDA 510(k) clearance for SELECT DEFENSE DENTAL PIT AND FISSURE S..., manufactured by Classone Orthodontics, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K093059 · Classone Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
127d
Days
Class 2
Risk

K093059 is an FDA 510(k) clearance for the SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Classone Orthodontics, Inc. (Lubbock, US). The FDA issued a Cleared decision on February 4, 2010 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Classone Orthodontics, Inc. devices

FDA 510(k) Submission Details - K093059

510(k) Number K093059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date February 04, 2010
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 97
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K093059.
ECO-S
K103121 · Vericom Co., Ltd. · Oct 2010
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010
SPK SEALANT
K091632 · 3M Company · Sep 2009
INFILTRATION KIT
K081493 · Dmg USA, Inc. · Sep 2008
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · CAO Group, Inc. · Nov 2006