Cleared Special

VITA VMK MASTER (K093446) - FDA 510(k) Clearance

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

K093446 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Dental device
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Dec 2009
Decision
28d
Days
Class 2
Risk

K093446 is an FDA 510(k) clearance for the VITA VMK MASTER. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (Brea, US). The FDA issued a Cleared decision on December 3, 2009 after a review of 28 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. Kg. devices

Submission Details

510(k) Number K093446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2009
Decision Date December 03, 2009
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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

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