Cleared Traditional

K091826 - ELEGANT

K091826 is an FDA 510(k) clearance for ELEGANT, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K091826 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
98d
Days
Class 2
Risk

K091826 is an FDA 510(k) clearance for the ELEGANT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on September 25, 2009 after a review of 98 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 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K091826

510(k) Number K091826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2009
Decision Date September 25, 2009
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K091826.
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
BELLUS SHADING KIT
K090718 · 3M Espe AG Dental Products · Sep 2009
QUATTRO PORCELAIN SYSTEM
K091706 · Dentsply International, Inc. · Aug 2009
GC AADVA ZR DISK
K082740 · GC America, Inc. · Nov 2008