Cleared Traditional

K052281 - EMBRACE WETBOND CLEAR SEALANT

K052281 is an FDA 510(k) clearance for EMBRACE WETBOND CLEAR 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 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

FDA 510(k) Submission Details - K052281

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.

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 105
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
RIVA PROTECT
K050871 · Southern Dental Industries, Inc. · Jun 2005