Cleared Traditional

K110050 - FIT TEST C&B

K110050 is the FDA 510(k) clearance for FIT TEST C&B by Voco GmbH. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K110050 · Voco GmbH · Dental device
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Mar 2011
Decision
80d
Days
Class 2
Risk

K110050 is an FDA 510(k) clearance for the FIT TEST C&B. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on March 28, 2011 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 K110050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2011
Decision Date March 28, 2011
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 114
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K110050.
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VIRTUAL
K060891 · Ivoclar Vivadent, Inc. · Jul 2006
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K061427 · Dentsply Intl. · Jun 2006