Cleared Special

K082740 - GC AADVA ZR DISK

K082740 is the FDA 510(k) clearance for GC AADVA ZR DISK by GC America, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Special 510(k) pathway after a 69-day FDA review.

K082740 · GC America, Inc. · Dental device
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Nov 2008
Decision
69d
Days
Class 2
Risk

K082740 is an FDA 510(k) clearance for the GC AADVA ZR DISK. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 69 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all GC America, Inc. devices

Submission Details

510(k) Number K082740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2008
Decision Date November 26, 2008
Days to Decision 69 days
Submission Type Special
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
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - EIH Powder, Porcelain

All 242
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K082740.
OBSIDIAN CERAMIC BLOCKS
K100781 · Prismatik Dentalcraft, Inc. · Jun 2010
VINTAGE MP
K093559 · Shofu Dental Corp. · Mar 2010
AADVA ZR COLORING LIQUID
K092020 · GC America, Inc. · Sep 2009
ZENO AI ECO DISC
K082257 · Wieland Dental + Technik GmbH & Co. KG · Sep 2008
VINTAGE ART
K080834 · Shofu Dental Corp. · Jun 2008
ZENO ZR DISC
K073108 · Wieland Dental + Technik GmbH & Co. KG · Nov 2007