Cleared Special

K060894 - BIFIX QM

K060894 is the FDA 510(k) clearance for BIFIX QM by Voco GmbH. It is a Class 2 Dental device (product code EMA) cleared through the Special 510(k) pathway after a 29-day FDA review.

K060894 · Voco GmbH · Dental device
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May 2006
Decision
29d
Days
Class 2
Risk

K060894 is an FDA 510(k) clearance for the BIFIX QM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on May 2, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 K060894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date May 02, 2006
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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.

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