Cleared Special

VITA IN-CERAM YZ CUBES FOR CEREC (K022996) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K022996 · Vident · Dental device
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Oct 2002
Decision
30d
Days
Class 2
Risk

K022996 is an FDA 510(k) clearance for the VITA IN-CERAM YZ CUBES FOR CEREC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Brea, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K022996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date October 09, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.

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