Cleared Abbreviated

K070699 - AVANTE Z

Also marketed or referenced as:
PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

K070699 is an FDA 510(k) clearance for AVANTE Z, manufactured by Pentron Ceramics, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K070699 · Pentron Ceramics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
108d
Days
Class 2
Risk

K070699 is an FDA 510(k) clearance for the AVANTE Z. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Pentron Ceramics, Inc. (Somerset, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 108 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K070699

510(k) Number K070699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date June 29, 2007
Days to Decision 108 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 128d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

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 K070699.
ARGEN PEARL BRAND ZIRCONIA
K071410 · The Argen Corporation · Aug 2007
GC-ZIRCONIA
K071674 · GC America, Inc. · Aug 2007
ZEO CE LIGHT & ZEO QUICK PORCELAIN
K071201 · Xpdent Corp · Jul 2007
ZIRBLOCK
K070537 · Cdl Technologies, Inc. · Apr 2007
PRESSX ZR
K070772 · Wieland Dental + Technik GmbH & Co. KG · Apr 2007
CYRTINA SYSTEM
K063842 · Oratio B.V. · Apr 2007
K070699 · AVANTE Z
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