Cleared Traditional

Grandio blocs (K171200) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171200 · Voco GmbH · Dental device
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Aug 2017
Decision
108d
Days
Class 2
Risk

K171200 is an FDA 510(k) clearance for the Grandio blocs. 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 August 10, 2017 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Voco GmbH devices

Submission Details

510(k) Number K171200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2017
Decision Date August 10, 2017
Days to Decision 108 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 127d · This submission: 108d
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 359
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K171200.
Trilor Disks, Blocks and Arches
K173643 · Bioloren S.R.L. · Feb 2018
Ecosite Bulk Fill
K171772 · Dmg USA, Inc. · Jan 2018
Registrado Scan
K171815 · Voco GmbH · Nov 2017
REVEAL Bulk
K171147 · Bisco, Inc. · Aug 2017
Admira Fusion x-base
K170896 · Voco GmbH · Jun 2017
Filtek One Bulk Fill Restorative
K163207 · 3M Company · Nov 2016