Cleared Traditional

K151956 - Admira Fusion x-tra

K151956 is the FDA 510(k) clearance for Admira Fusion x-tra by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K151956 · Voco GmbH · Dental device
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Oct 2015
Decision
97d
Days
Class 2
Risk

K151956 is an FDA 510(k) clearance for the Admira Fusion x-tra. 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 October 20, 2015 after a review of 97 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 K151956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2015
Decision Date October 20, 2015
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
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 424
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K151956.
Gradia Plus
K153325 · GC America, Inc. · Jul 2016
Admira Fusion Flow
K153177 · Voco GmbH · Jun 2016
everX Posterior
K153127 · GC America, Inc. · May 2016
G-Fix
K151541 · GC America, Inc. · Oct 2015
Mosaic Universal Composite
K151094 · Ultradent Products, Inc. · Jul 2015
Admira Fusion
K150784 · Voco GmbH · Jul 2015