Cleared Special

K051867 - GRANDIO

K051867 is the FDA 510(k) clearance for GRANDIO by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Special 510(k) pathway after a 16-day FDA review.

K051867 · Voco GmbH · Dental device
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Jul 2005
Decision
16d
Days
Class 2
Risk

K051867 is an FDA 510(k) clearance for the GRANDIO. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (Bend, US). The FDA issued a Cleared decision on July 27, 2005 after a review of 16 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 K051867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2005
Decision Date July 27, 2005
Days to Decision 16 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
111d faster than avg
Panel avg: 127d · This submission: 16d
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
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K051867.
MODIFICATION TO REBILDA DC
K060893 · Voco GmbH · May 2006
X-TRA FIL
K053391 · Voco GmbH · Feb 2006
BEAUTIFIL FLOW
K051818 · Shofu Dental Corp. · Aug 2005
GRANDIO FLOW
K051868 · Voco GmbH · Jul 2005
CERAMAGE
K050401 · Shofu Dental Corp. · Apr 2005
DYRACT EXTRA RESTORATIVE
K050880 · Dentsply Intl. · Apr 2005