Cleared Traditional

K083438 - BIFIX SE

K083438 is the FDA 510(k) clearance for BIFIX SE by Voco GmbH. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K083438 · Voco GmbH · Dental device
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Feb 2009
Decision
85d
Days
Class 2
Risk

K083438 is an FDA 510(k) clearance for the BIFIX SE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on February 13, 2009 after a review of 85 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. 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 K083438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2008
Decision Date February 13, 2009
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.