Cleared Traditional

K092281 - CLEARFIL MAJESTY POSTERIOR PLT

K092281 is the FDA 510(k) clearance for CLEARFIL MAJESTY POSTERIOR PLT by Kuraray Medical, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K092281 · Kuraray Medical, Inc. · Dental device
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Oct 2009
Decision
90d
Days
Class 2
Risk

K092281 is an FDA 510(k) clearance for the CLEARFIL MAJESTY POSTERIOR PLT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Kuraray Medical, Inc. devices

Submission Details

510(k) Number K092281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date October 27, 2009
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 515
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K092281.
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K090704 · Ivoclar Vivadent, Inc. · Jun 2009