Cleared Traditional

K092630 - ZIROX

K092630 is an FDA 510(k) clearance for ZIROX, manufactured by Zencera, 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.

K092630 · Zencera, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
56d
Days
Class 2
Risk

K092630 is an FDA 510(k) clearance for the ZIROX. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Zencera, Inc. (Seoul, KR). The FDA issued a Cleared decision on October 22, 2009 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.

FDA 510(k) Submission Details - K092630

510(k) Number K092630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2009
Decision Date October 22, 2009
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
72d faster than avg
Panel avg: 128d · 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 479
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K092630.
DD BIO Z AND DD BIO Z - TRANSPA
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ELEGANT
K091826 · 3M Espe AG Dental Products · Sep 2009
K092630 · ZIROX
Download PDF FDA Summary Zencera, Inc.