Cleared Traditional

K122521 - PREVENT SEAL (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122521 · Itena Clinical · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
295d
Days
Class 2
Risk

K122521 is an FDA 510(k) clearance for the PREVENT SEAL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Itena Clinical (Laval, CA). The FDA issued a Cleared decision on June 11, 2013 after a review of 295 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 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 Itena Clinical devices

Submission Details

510(k) Number K122521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2012
Decision Date June 11, 2013
Days to Decision 295 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 127d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K122521.
Any-Com Seal
K260819 · Mediclus Co., Ltd. · May 2026
Parkell Pit and Fissure Sealant
K243254 · Parkell, Inc. · Aug 2025
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498 · Ultradent Product, Inc. · Aug 2023
Enamel Coating Resin
K230455 · Rizhao Huge Biomaterials Company, Ltd. · Jul 2023
Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019