Cleared Traditional

K120134 - IPS E.MAX PRESS MULTI

K120134 is the FDA 510(k) clearance for IPS E.MAX PRESS MULTI by Ivoclar Vivadent, AG. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K120134 · Ivoclar Vivadent, AG · Dental device
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Jun 2012
Decision
160d
Days
Class 2
Risk

K120134 is an FDA 510(k) clearance for the IPS E.MAX PRESS MULTI. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on June 25, 2012 after a review of 160 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.

View all Ivoclar Vivadent, AG devices

Submission Details

510(k) Number K120134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date June 25, 2012
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
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 K120134.
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K103556 · Ivoclar Vivadent, Inc. · Apr 2011