Cleared Traditional

K020432 - PULPDENT GLAZE

K020432 is the FDA 510(k) clearance for PULPDENT GLAZE by Pulpdent Corporation. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K020432 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
68d
Days
Class 2
Risk

K020432 is an FDA 510(k) clearance for the PULPDENT GLAZE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K020432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2002
Decision Date April 17, 2002
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 517
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K020432.
CLEARFIL AP-X PLT
K023002 · Kuraray Medical, Inc. · Oct 2002
CLEARFIL AP-X PLT INTRO KIT
K022999 · Kuraray Medical, Inc. · Oct 2002
TWINKY STAR
K022797 · Voco GmbH · Oct 2002
UNIFIL FLOW
K020342 · GC America, Inc. · Mar 2002
REBILDA SC
K014111 · Voco GmbH · Mar 2002
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · Heraeus Kulzer, Inc. · Feb 2002