Cleared Traditional

K052281 - EMBRACE WETBOND CLEAR SEALANT

K052281 is the FDA 510(k) clearance for EMBRACE WETBOND CLEAR SEALANT by Pulpdent Corporation. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K052281 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
170d
Days
Class 2
Risk

K052281 is an FDA 510(k) clearance for the EMBRACE WETBOND CLEAR SEALANT. 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 February 8, 2006 after a review of 170 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 Pulpdent Corporation devices

Submission Details

510(k) Number K052281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date February 08, 2006
Days to Decision 170 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
43d slower than avg
Panel avg: 127d · This submission: 170d
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 76
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K052281.
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · Premier Dental Products Co. · Oct 2006
GRANDIO SEAL
K062344 · Voco GmbH · Oct 2006
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K061823 · Voco GmbH · Jul 2006
ASCENT PIT & FISSURE SEALANT
K053089 · CAO Group, Inc. · Dec 2005
BOSWORTH SEAL
K051224 · Harry J. Bosworth Co. · Jul 2005
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751 · Harry J. Bosworth Co. · Feb 2004