Cleared Traditional

K033049 - CZR PRESS

K033049 is the FDA 510(k) clearance for CZR PRESS by Noritake Co., Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K033049 · Noritake Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
25d
Days
Class 2
Risk

K033049 is an FDA 510(k) clearance for the CZR 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 October 24, 2003 after a review of 25 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 K033049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date October 24, 2003
Days to Decision 25 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
102d faster than avg
Panel avg: 127d · This submission: 25d
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 K033049.
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
K032416 · Shofu Dental Corp. · Feb 2004
CARRARA PRESS SYSTEM
K033667 · Dentsply Intl. · Jan 2004
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
VINTAGE AL
K032165 · Shofu Dental Corp. · Sep 2003
IMAGINE REFLEX
K031326 · Wieland Dental + Technik GmbH & Co. KG · Jun 2003
VITA IN-CERAM YZ CUBES FOR CEREC
K022996 · Vident · Oct 2002