Cleared Traditional

K020432 - PULPDENT GLAZE

K020432 is an FDA 510(k) clearance for PULPDENT GLAZE, manufactured by Pulpdent Corporation. The device is a Class 2 Dental device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K020432

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 128d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 934
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K020432.
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
K020113 · Vector Research & Development · May 2002
STARFLOW HV
K020760 · Danville Materials, Inc. · May 2002
SONATA MICRO HYBRID COMPOSITE
K020555 · Pentron Laboratory Technologies · Apr 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
K020432 · PULPDENT GLAZE
Download PDF FDA Summary Pulpdent Corporation