Cleared Special

MODIFICATION TO:REGISTRADO X-TRA (K051535) - FDA 510(k) Clearance

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

K051535 · Voco GmbH · Dental device
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Jun 2005
Decision
18d
Days
Class 2
Risk

K051535 is an FDA 510(k) clearance for the MODIFICATION TO:REGISTRADO X-TRA. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Voco GmbH (Bend, US). The FDA issued a Cleared decision on June 28, 2005 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Voco GmbH devices

Submission Details

510(k) Number K051535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2005
Decision Date June 28, 2005
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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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