Cleared Traditional

K080146 - ZIRKONDENT

K080146 is an FDA 510(k) clearance for ZIRKONDENT, manufactured by Ergometa. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K080146 · Ergometa · Dental device
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Jun 2008
Decision
136d
Days
Class 2
Risk

K080146 is an FDA 510(k) clearance for the ZIRKONDENT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ergometa (Aliso Viejo, US). The FDA issued a Cleared decision on June 6, 2008 after a review of 136 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 Ergometa devices

FDA 510(k) Submission Details - K080146

510(k) Number K080146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2008
Decision Date June 06, 2008
Days to Decision 136 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 127d · This submission: 136d
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 319
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K080146.
GC AADVA ZR DISK
K082740 · GC America, Inc. · Nov 2008
ZENO AI ECO DISC
K082257 · Wieland Dental + Technik GmbH & Co. KG · Sep 2008
VINTAGE ART
K080834 · Shofu Dental Corp. · Jun 2008
DENTAL CERAMIC
K080479 · Dmg USA, Inc. · May 2008
ZENO ZR DISC
K073108 · Wieland Dental + Technik GmbH & Co. KG · Nov 2007
IPS INLINE POM SYSTEM
K071848 · Ivoclar Vivadent, Inc. · Aug 2007