Cleared Traditional

K083438 - BIFIX SE (FDA 510(k) Clearance)

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

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

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on February 13, 2009, 85 days after receiving the submission on November 20, 2008.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

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

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.3275