Cleared Traditional

K020514 - PULPDENT GLAZE II

K020514 is the FDA 510(k) clearance for PULPDENT GLAZE II by Pulpdent Corporation. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020514 · Pulpdent Corporation · Dental device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
90d
Days
Class 2
Risk

K020514 is an FDA 510(k) clearance for the PULPDENT GLAZE II. 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 May 16, 2002 after a review of 90 days - within the typical 510(k) review window.

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: 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 K020514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2002
Decision Date May 16, 2002
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 249
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K020514.
IBOND GLUMA INSIDE
K022612 · Heraeus Kulzer, Inc. · Oct 2002
PQ1
K023042 · Ultradent Products, Inc. · Oct 2002
CLEARFIL SA PRIMER
K021427 · Kuraray Medical, Inc. · Jun 2002
BOND-3 ADHESIVE
K020499 · Jeneric/Pentron, Inc. · Apr 2002
TOUCH&BOND-PLUS
K020239 · Parkell, Inc. · Mar 2002
BOND-1 C & B
K013543 · Jeneric/Pentron, Inc. · Feb 2002