Cleared Special

K103580 - GRANDIO SO FLOW

K103580 is the FDA 510(k) clearance for GRANDIO SO FLOW by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Special 510(k) pathway after a 46-day FDA review.

K103580 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
46d
Days
Class 2
Risk

K103580 is an FDA 510(k) clearance for the GRANDIO SO FLOW. 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 January 21, 2011 after a review of 46 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 K103580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date January 21, 2011
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
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 479
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K103580.
TETRIC EVOCERAM BULK FILL
K111958 · Ivoclar Vivadent, Inc. · Oct 2011
CIMARA
K110589 · Voco GmbH · May 2011
IPS EMPRESS DIRECT FLOW
K103528 · Ivoclar Vivadent, Inc. · Feb 2011
GRANDIO SO HEAVY FLOW
K102354 · Voco GmbH · Nov 2010
GRANDIO SO
K102351 · Voco GmbH · Nov 2010
IONOLUX PRO
K102450 · Voco GmbH · Oct 2010