Cleared Traditional

K992024 - SUPER PORCELAIN TI-22

K992024 is the FDA 510(k) clearance for SUPER PORCELAIN TI-22 by Noritake Co., Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K992024 · Noritake Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
72d
Days
Class 2
Risk

K992024 is an FDA 510(k) clearance for the SUPER PORCELAIN TI-22. 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 August 27, 1999 after a review of 72 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 K992024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1999
Decision Date August 27, 1999
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
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 K992024.
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435 · Jeneric/Pentron, Inc. · Feb 2000
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
OPC LOW WEAR OPAQUE PORCELAIN
K993249 · Jeneric/Pentron, Inc. · Nov 1999
IPS D.SIGN PORCELAIN
K990817 · Ivoclar North America, Inc. · Apr 1999
IPS EMPRESS 2
K982616 · Ivoclar North America, Inc. · Sep 1998
OPC LOWWEAR PORCELAIN
K982377 · Jeneric/Pentron, Inc. · Aug 1998