Cleared Special

K201307 - VisCalor

K201307 is the FDA 510(k) clearance for VisCalor by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Special 510(k) pathway after a 54-day FDA review.

K201307 · Voco GmbH · Dental device
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Jul 2020
Decision
54d
Days
Class 2
Risk

K201307 is an FDA 510(k) clearance for the VisCalor. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 8, 2020 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K201307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2020
Decision Date July 08, 2020
Days to Decision 54 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
73d faster than avg
Panel avg: 127d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 516
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