Cleared Traditional

K050144 - PRISMATIK CERAMIC

K050144 is an FDA 510(k) clearance for PRISMATIK CERAMIC, manufactured by Glidewell Laboratories. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K050144 · Glidewell Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
38d
Days
Class 2
Risk

K050144 is an FDA 510(k) clearance for the PRISMATIK CERAMIC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Glidewell Laboratories (Newport Beach, US). The FDA issued a Cleared decision on March 3, 2005 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Glidewell Laboratories devices

FDA 510(k) Submission Details - K050144

510(k) Number K050144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2005
Decision Date March 03, 2005
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 325
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K050144.
XAWEX G 100
K050903 · Wieland Dental + Technik GmbH & Co. KG · Jun 2005
THE LF-P CERAMIC SYSTEM
K050838 · Jensen Industries, Inc. · May 2005
VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
K050362 · Vident · Mar 2005
ALLUX
K050203 · Wieland Dental + Technik GmbH & Co. KG · Feb 2005
WILLI GELLER CREATION ZI PORCELAIN
K043201 · Jensen Industries, Inc. · Jan 2005
DUCERA ALLCERAM
K043247 · Dentsply Intl. · Dec 2004