Cleared Traditional

Bifix Hybrid Abutment Cement

K220640 · Voco GmbH · Dental
Aug 2022
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K220640 is an FDA 510(k) clearance for the Bifix Hybrid Abutment Cement, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on August 23, 2022, 172 days after receiving the submission on March 4, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K220640 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2022
Decision Date August 23, 2022
Days to Decision 172 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