Cleared Abbreviated

BA Pit & Fissure Sealant (K190998) - FDA 510(k) Clearance

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

K190998 · Apex Dental Materials, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
206d
Days
Class 2
Risk

K190998 is an FDA 510(k) clearance for the BA Pit & Fissure Sealant. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 206 days - an extended review 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 Apex Dental Materials, Inc. devices

Submission Details

510(k) Number K190998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2019
Decision Date November 08, 2019
Days to Decision 206 days
Submission Type Abbreviated
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
79d slower than avg
Panel avg: 127d · This submission: 206d
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 K190998.
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Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018