Cleared Traditional

K121230 - IPS EMPRESS DIRECT COLOR IPS EMPRESS DI...

K121230 is the FDA 510(k) clearance for IPS EMPRESS DIRECT COLOR IPS EMPRESS DI... by Ivoclar Vivadent, AG. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K121230 · Ivoclar Vivadent, AG · Dental device
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Aug 2012
Decision
127d
Days
Class 2
Risk

K121230 is an FDA 510(k) clearance for the IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on August 29, 2012 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K121230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2012
Decision Date August 29, 2012
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 517
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