Cleared Abbreviated

K243254 - Parkell Pit and Fissure Sealant (FDA 510(k) Clearance)

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

K243254 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
297d
Days
Class 2
Risk

K243254 is an FDA 510(k) clearance for the Parkell Pit and Fissure Sealant. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on August 8, 2025 after a review of 297 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 Parkell, Inc. devices

Submission Details

510(k) Number K243254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2024
Decision Date August 08, 2025
Days to Decision 297 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
170d slower than avg
Panel avg: 127d · This submission: 297d
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 Consultant

Fish & Richardson, P.C.
Keith Barritt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.