Cleared Traditional

K122521 - PREVENT SEAL

K122521 is an FDA 510(k) clearance for PREVENT SEAL, manufactured by Itena Clinical. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 295-day FDA review.

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

FDA 510(k) Submission Details - K122521

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.

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 92
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K122521.
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018
HAPI Seal
K162598 · Bisco, Inc. · May 2017
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · Pulpdent Corporation · Mar 2012
ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011