Cleared Abbreviated

K043468 - WILLI GELLER CREATION II PORCELAIN

K043468 is an FDA 510(k) clearance for WILLI GELLER CREATION II PORCELAIN, manufactured by Jensen Int'L, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 27-day FDA review.

K043468 · Jensen Int'L, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
27d
Days
Class 2
Risk

K043468 is an FDA 510(k) clearance for the WILLI GELLER CREATION II PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Jensen Int'L, Inc. (North Haven, US). The FDA issued a Cleared decision on January 12, 2005 after a review of 27 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Jensen Int'L, Inc. devices

FDA 510(k) Submission Details - K043468

510(k) Number K043468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date January 12, 2005
Days to Decision 27 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 127d · This submission: 27d
Pathway characteristics
Standards-based clearance path.

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 337
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K043468.
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K043221 · Jensen Industries, Inc. · Dec 2004