Cleared Traditional

K061804 - ZERION ALPHA,

Also marketed or referenced as:
ZERION BETA

K061804 is an FDA 510(k) clearance for ZERION ALPHA, manufactured by Etkon International GmbH. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K061804 · Etkon International GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
101d
Days
Class 2
Risk

K061804 is an FDA 510(k) clearance for the ZERION ALPHA,. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Etkon International GmbH (Graefelfing, Bavaria, DE). The FDA issued a Cleared decision on October 6, 2006 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061804

510(k) Number K061804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2006
Decision Date October 06, 2006
Days to Decision 101 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
27d faster than avg
Panel avg: 128d · This submission: 101d
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 479
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K061804.
CERAMILL ZI
K063511 · Amann Girrbach America, Inc. · Feb 2007
CARRARA VOLUMIA
K070019 · Dentsply Intl. · Jan 2007
SAGEMAX Z-BLANK
K062695 · Sagemax Bioceramics, Inc. · Oct 2006
ZIRKONZAHN ICE
K061851 · Zirkonzahn GmbH · Sep 2006
INCORIS ZI
K062509 · Sirona Dental Systems GmbH · Sep 2006
INCORIS AL
K062506 · Sirona Dental Systems GmbH · Sep 2006
K061804 · ZERION ALPHA,
Download PDF FDA Summary Etkon International G…