Cleared Abbreviated

K110058 - BPA-FREE PIT AND FISSURE SEALANT

K110058 is an FDA 510(k) clearance for BPA-FREE PIT AND FISSURE SEALANT, manufactured by Novocol Inc. Dba Septodont and Confi-Dental Produc. The device is a Class 2 Dental device with product code EBC cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

K110058 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Dental device
Download Printable Device Report (PDF)
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Mar 2011
Decision
80d
Days
Class 2
Risk

K110058 is an FDA 510(k) clearance for the BPA-FREE PIT AND FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Novocol Inc. Dba Septodont and Confi-Dental Produc (Louisville, US). The FDA issued a Cleared decision on March 31, 2011 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Novocol Inc. Dba Septodont and Confi-Dental Produc devices

FDA 510(k) Submission Details - K110058

510(k) Number K110058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2011
Decision Date March 31, 2011
Days to Decision 80 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

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 96
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K110058.
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
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ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
ECO-S
K103121 · Vericom Co., Ltd. · Oct 2010
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010