Cleared Traditional

K033117 - GRANDIO FLOW

K033117 is the FDA 510(k) clearance for GRANDIO FLOW by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K033117 · Voco GmbH · Dental device
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Nov 2003
Decision
56d
Days
Class 2
Risk

K033117 is an FDA 510(k) clearance for the GRANDIO FLOW. 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 November 25, 2003 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Voco GmbH devices

Submission Details

510(k) Number K033117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date November 25, 2003
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K033117.
GRADIA GUM
K033808 · GC America, Inc. · Feb 2004
VENUS FLOW
K033665 · Heraeus Kulzer, Inc. · Dec 2003
EPRICORD
K033267 · Kuraray Medical, Inc. · Dec 2003
PREMISE
K032921 · Sybron Dental Specialties, Inc. · Nov 2003
TESCERAFLO A2, MODEL T-21012P
K030951 · Bisco, Inc. · Jun 2003
REBILDA DC
K030914 · Voco GmbH · May 2003