Cleared Traditional

K002041 - WILLI GELLER CREATION & AV PORCELAIN

K002041 is the FDA 510(k) clearance for WILLI GELLER CREATION & AV PORCELAIN by Jensen Industries, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K002041 · Jensen Industries, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
42d
Days
Class 2
Risk

K002041 is an FDA 510(k) clearance for the WILLI GELLER CREATION & AV PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Jensen Industries, Inc. (North Haven, US). The FDA issued a Cleared decision on August 16, 2000 after a review of 42 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 Jensen Industries, Inc. devices

Submission Details

510(k) Number K002041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2000
Decision Date August 16, 2000
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 261
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K002041.
AVANTE MICRO CRYSTAL SYSTEM
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PROCAD ADD-ON
K003373 · Ivoclar North America, Inc. · Nov 2000
HERACERAM
K002993 · J.F. Jelenko & Co., Inc. · Nov 2000
VITA RESPONSE
K000597 · Vident · May 2000
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435 · Jeneric/Pentron, Inc. · Feb 2000
3M TR SYSTEM
K992489 · 3M Company · Jan 2000