Cleared Special

K090644 - VITABLOCS

K090644 is an FDA 510(k) clearance for VITABLOCS, manufactured by Vita Zahnfabrik H.Rauter GmbH & Co.. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 21-day FDA review.

K090644 · Vita Zahnfabrik H.Rauter GmbH & Co. · Dental device
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Mar 2009
Decision
21d
Days
Class 2
Risk

K090644 is an FDA 510(k) clearance for the VITABLOCS, MODEL VX55-****. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Brea, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 21 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 Vita Zahnfabrik H.Rauter GmbH & Co. devices

FDA 510(k) Submission Details - K090644

510(k) Number K090644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2009
Decision Date March 31, 2009
Days to Decision 21 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
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

EIH Device Classification - Class 2, Special Controls

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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