Cleared Traditional

K113818 - EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL

K113818 is an FDA 510(k) clearance for EMBRACE WETBOND PIT AND FISSURE SEALANT, manufactured by Pulpdent Corporation. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K113818 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K113818

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
Combination Product No
PCCP Authorized No
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.

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 104
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K113818.
PACSEAL PIT & FISSURE SEALANT
K141717 · Pac-Dent International, Inc. · Mar 2015
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
PREVENT SEAL
K122521 · Itena Clinical · Jun 2013
ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
BPA-FREE PIT AND FISSURE SEALANT
K110058 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Mar 2011