Cleared Traditional

K121230 - IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE

K121230 is an FDA 510(k) clearance for IPS EMPRESS DIRECT COLOR IPS EMPRESS DI..., manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K121230

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
Combination Product No
PCCP Authorized No
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.

EBF Device Classification - Class 2, Special Controls

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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K121230.
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