Cleared Abbreviated

BPA-FREE PIT AND FISSURE SEALANT (K110058) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K110058 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Dental device
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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

Submission Details

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.

Device Classification

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 130
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K110058.
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