Cleared Traditional

K052304 - SUPER PORCELAIN EX-3 PRESS

K052304 is the FDA 510(k) clearance for SUPER PORCELAIN EX-3 PRESS by Noritake Co., Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K052304 · Noritake Co., Inc. · Dental device
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Nov 2005
Decision
91d
Days
Class 2
Risk

K052304 is an FDA 510(k) clearance for the SUPER PORCELAIN EX-3 PRESS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Noritake Co., Inc. (Washington, US). The FDA issued a Cleared decision on November 23, 2005 after a review of 91 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 Noritake Co., Inc. devices

Submission Details

510(k) Number K052304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2005
Decision Date November 23, 2005
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 261
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K052304.
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