Cleared Special

K060894 - BIFIX QM (FDA 510(k) Clearance)

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

K060894 is an FDA 510(k) clearance for the BIFIX QM. 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 May 2, 2006, 29 days after receiving the submission on April 3, 2006.

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

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

Device Classification

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