Cleared Traditional

K092176 - TAKE 1 ADVANCED RIGID TRAY

K092176 is the FDA 510(k) clearance for TAKE 1 ADVANCED RIGID TRAY by Kerr Corporation. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K092176 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
191d
Days
Class 2
Risk

K092176 is an FDA 510(k) clearance for the TAKE 1 ADVANCED RIGID TRAY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on January 28, 2010 after a review of 191 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Kerr Corporation devices

Submission Details

510(k) Number K092176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date January 28, 2010
Days to Decision 191 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 127d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 141
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K092176.
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
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FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
FLEXITIME FLOW
K091494 · Heraeus Kulzer, Inc. · Jul 2009
CEREC OPTI SPRAY
K080882 · Sirona Dental Systems GmbH · Apr 2008
VIRTUAL
K060891 · Ivoclar Vivadent, Inc. · Jul 2006