Cleared Traditional

K983470 - SUPER PORCELAIN STAIN- PURE WHITE

K983470 is an FDA 510(k) clearance for SUPER PORCELAIN STAIN- PURE WHITE, 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 82-day FDA review.

K983470 · Noritake Co., Inc. · Dental device
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Dec 1998
Decision
82d
Days
Class 2
Risk

K983470 is an FDA 510(k) clearance for the SUPER PORCELAIN STAIN- PURE WHITE. 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 December 22, 1998 after a review of 82 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

FDA 510(k) Submission Details - K983470

510(k) Number K983470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1998
Decision Date December 22, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
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 403
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K983470.
VISION PORCELAIN
K990790 · Servo Dental USA, Inc. · Apr 1999
SYMBIOCERAM
K990629 · Ney Dental, Inc. · Mar 1999
EXCELSIOR PORCELAIN SYSTEM
K984427 · Ney Dental, Inc. · Mar 1999
PROCERA ALLCERAM FUSING MATERIAL
K983453 · Nobel Biocare Uas, Inc. · Nov 1998
SUPER PORCELAIN ADDMATE
K983247 · Noritake Co., Inc. · Nov 1998
PASTE OPAQUE EX-3
K982766 · Noritake Co., Inc. · Oct 1998