Cleared Traditional

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (K113818) - FDA 510(k) Clearance

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

K113818 · Pulpdent Corporation · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2012
Decision
85d
Days
Class 2
Risk

K113818 is an FDA 510(k) clearance for the EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 21, 2012 after a review of 85 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corporation devices

Submission Details

510(k) Number K113818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date March 21, 2012
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K113818.
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