Cleared Traditional

K111107 - SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE

K111107 is the FDA 510(k) clearance for SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE by Noritake Co., Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K111107 · Noritake Co., Inc. · Dental device
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Jun 2011
Decision
71d
Days
Class 2
Risk

K111107 is an FDA 510(k) clearance for the SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE. 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 June 30, 2011 after a review of 71 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Noritake Co., Inc. devices

Submission Details

510(k) Number K111107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2011
Decision Date June 30, 2011
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 K111107.
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