Cleared Traditional

K032953 - EMBRACE WETBOND RESTORATION AND PFM REP...

K032953 is the FDA 510(k) clearance for EMBRACE WETBOND RESTORATION AND PFM REP... by Pulpdent Corporation. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K032953 · Pulpdent Corporation · Dental device
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Dec 2003
Decision
79d
Days
Class 2
Risk

K032953 is an FDA 510(k) clearance for the EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on December 10, 2003 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 K032953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date December 10, 2003
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 282
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K032953.
M.L. PRIMER
K040079 · Shofu Dental Corp. · Sep 2004
G-BOND
K041471 · GC America, Inc. · Jun 2004
CLEARFIL PROTECT BOND
K033938 · Kuraray Medical, Inc. · Jan 2004
PERMAQUICK SE BONDING SYSTEM
K032626 · Ultradent Products, Inc. · Dec 2003
COMP. E
K032179 · Parkell, Inc. · Sep 2003
PULPDENT ETCH-RITE ROYALE
K031915 · Pulpdent Corporation · Aug 2003