Cleared Special

K082740 - GC AADVA ZR DISK

K082740 is an FDA 510(k) clearance for GC AADVA ZR DISK, manufactured by GC America, Inc.. The device is a Class 2 Dental device with 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.

FDA 510(k) Submission Details - K082740

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
59d faster than avg
Panel avg: 128d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K082740.
DLMS-ZIRBLOCKS
K082137 · Dental Milling Laboratory Supplies (Dlms) · Feb 2009
ZMATCH BLOCK
K083201 · Dentaim Co., Ltd. · Jan 2009
BITTAR ZIRCONIA BLOCKS
K082652 · Bittar Zirconia Block, LLC · Dec 2008
DENSEO FAIRY
K082158 · Xpdent Corp · Oct 2008
AVANTE Z ZIRCONIA (AS)3 BLOCKS
K081749 · Pentron Ceramics, Inc. · Sep 2008
BISQUE ZIRCONIA BLANKS, TYPE BYZ
K081850 · Zircar Zirconia, Inc. · Sep 2008
K082740 · GC AADVA ZR DISK
Download PDF GC America, Inc.