Cleared Traditional

K031968 - CERABIEN ZR

K031968 is an FDA 510(k) clearance for CERABIEN ZR, 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 179-day FDA review.

K031968 · Noritake Co., Inc. · Dental device
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Dec 2003
Decision
179d
Days
Class 2
Risk

K031968 is an FDA 510(k) clearance for the CERABIEN ZR. 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, 2003 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031968

510(k) Number K031968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2003
Decision Date December 22, 2003
Days to Decision 179 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
51d slower than avg
Panel avg: 128d · This submission: 179d
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 K031968.
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
K032416 · Shofu Dental Corp. · Feb 2004
CARRARA PRESS SYSTEM
K033667 · Dentsply Intl. · Jan 2004
MATCH MASTER LOW FUSION PORCELAIN
K024252 · Davis Schottlander & Davis, Ltd. · Jan 2004
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
KAVO EVEREST ZH-BLANK
K033221 · Kavo America Corporation · Oct 2003
CZR PRESS
K033049 · Noritake Co., Inc. · Oct 2003
K031968 · CERABIEN ZR
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