Cleared Traditional

K884356 - NORITAKE SUPER PORCELAIN EX-3

K884356 is an FDA 510(k) clearance for NORITAKE SUPER PORCELAIN EX-3, manufactured by Noritake Co., Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K884356 · Noritake Co., Inc. · Dental device
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Jan 1989
Decision
85d
Days
Class 2
Risk

K884356 is an FDA 510(k) clearance for the NORITAKE SUPER PORCELAIN EX-3. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Noritake Co., Inc. (Secaucus, US). The FDA issued a Cleared decision on January 10, 1989 after a review of 85 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.

FDA 510(k) Submission Details - K884356

510(k) Number K884356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1988
Decision Date January 10, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 128d · This submission: 85d
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 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K884356.
SILHOUETTE PORCELAIN
K895888 · Leach and Dillon Co., Inc. · Apr 1990
WILLI GELLER CERAMIC CREATION & SURPRISE
K900209 · Creation North America, Inc. · Apr 1990
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895889 · Leach and Dillon Co., Inc. · Apr 1990
PENTRON HIGH STRENGTH PORCELAIN
K864404 · Pentron Corp. · Nov 1986
TRU-COLOR
K855037 · Veritas Dental Co., Inc. · Mar 1986
CERAPEARL
K854763 · Kyocera International, Inc. · Feb 1986
K884356 · NORITAKE SUPER PORCELAIN EX-3
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