Cleared Traditional

K001815 - DC ZIRKON

K001815 is an FDA 510(k) clearance for DC ZIRKON, manufactured by Austenal, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K001815 · Austenal, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
56d
Days
Class 2
Risk

K001815 is an FDA 510(k) clearance for the DC ZIRKON. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Austenal, Inc. (Chicago, US). The FDA issued a Cleared decision on August 10, 2000 after a review of 56 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 Austenal, Inc. devices

FDA 510(k) Submission Details - K001815

510(k) Number K001815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2000
Decision Date August 10, 2000
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 320
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K001815.
HERACERAM
K002993 · J.F. Jelenko & Co., Inc. · Nov 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904 · Jensen Industries, Inc. · Nov 2000
WILLI GELLER CREATION & AV PORCELAIN
K002041 · Jensen Industries, Inc. · Aug 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