Cleared Traditional

ZERION ALPHA, (K061804) - FDA 510(k) Clearance

Also marketed or referenced as:
ZERION BETA

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061804 · Etkon International GmbH · Dental device
Download Printable Device Report (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.

View all Etkon International GmbH devices

Submission Details

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
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
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.

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