Cleared Traditional

K040599 - PARKELL RESIN GLAZE

K040599 is the FDA 510(k) clearance for PARKELL RESIN GLAZE by Parkell, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K040599 · Parkell, Inc. · Dental device
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Apr 2004
Decision
32d
Days
Class 2
Risk

K040599 is an FDA 510(k) clearance for the PARKELL RESIN GLAZE. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 9, 2004 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Parkell, Inc. devices

Submission Details

510(k) Number K040599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2004
Decision Date April 09, 2004
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 32
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K040599.
G-COAT
K052462 · GC America, Inc. · Oct 2005
BISCOVER LED
K051999 · Bisco, Inc. · Aug 2005
BISCOVER LV
K043168 · Bisco, Inc. · Feb 2005
SCULPTING RESIN
K030585 · Bisco, Inc. · Apr 2003
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
K030354 · Bisco, Inc. · Feb 2003
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
K024046 · Bisco, Inc. · Feb 2003