Cleared Traditional

K113431 - CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA

K113431 is an FDA 510(k) clearance for CERAMIC PRODUCTS MADE IN YTTRIA-STABILI..., manufactured by Bettini S.P.A.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K113431 · Bettini S.P.A. · Dental device
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Mar 2012
Decision
130d
Days
Class 2
Risk

K113431 is an FDA 510(k) clearance for the CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Bettini S.P.A. (Ormond Beach, US). The FDA issued a Cleared decision on March 30, 2012 after a review of 130 days - within the typical 510(k) review window.

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 - K113431

510(k) Number K113431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date March 30, 2012
Days to Decision 130 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
2d slower than avg
Panel avg: 128d · This submission: 130d
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 482
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K113431.
IPS 99 ONE AND IPS 99 CERAM
K121359 · Ivoclar Vivadent, AG · Jul 2012
IPS E.MAX PRESS MULTI
K120134 · Ivoclar Vivadent, AG · Jun 2012
ZIRCONIA BLANKS (ZIRCOSTAR)
K120852 · Kerox, Ltd. · Jun 2012
HILLA DIGITAL TRANSFERS
K113575 · Hilla Technologies, Inc. · Mar 2012
HEISENBERG EFFECT SHADES
K120011 · 3M Espe AG · Jan 2012
JENSEN ZIRCONIA
K112806 · Jensen Industries, Inc. · Dec 2011
K113431 · CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
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