Cleared Abbreviated

K090684 - AVANTE LEUCITE BLOCKS

K090684 is an FDA 510(k) clearance for AVANTE LEUCITE BLOCKS, manufactured by Somerset Dental Products, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 46-day FDA review.

K090684 · Somerset Dental Products, Inc. · Dental device
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May 2009
Decision
46d
Days
Class 2
Risk

K090684 is an FDA 510(k) clearance for the AVANTE LEUCITE BLOCKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Somerset Dental Products, Inc. (Somerset, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 46 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 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 - K090684

510(k) Number K090684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date May 01, 2009
Days to Decision 46 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
82d faster than avg
Panel avg: 128d · This submission: 46d
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 K090684.
QUATTRO PORCELAIN SYSTEM
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DLMS-ZIRBLOCKS
K082137 · Dental Milling Laboratory Supplies (Dlms) · Feb 2009
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K083201 · Dentaim Co., Ltd. · Jan 2009
K090684 · AVANTE LEUCITE BLOCKS
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