Cleared Special

K022996 - VITA IN-CERAM YZ CUBES FOR CEREC

K022996 is the FDA 510(k) clearance for VITA IN-CERAM YZ CUBES FOR CEREC by Vident. It is a Class 2 Dental device (product code EIH) cleared through the Special 510(k) pathway after a 30-day FDA review.

K022996 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Vident devices

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K022996.
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
VINTAGE AL
K032165 · Shofu Dental Corp. · Sep 2003
IMAGINE REFLEX
K031326 · Wieland Dental + Technik GmbH & Co. KG · Jun 2003
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
IMAGINE H.E. PRESS DESIGN-CERAMIC
K020774 · Wieland Dental + Technik GmbH & Co. KG · May 2002
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc. · Aug 2001