Bifix Hybrid Abutment Cement
K-Number: K220640 · 2022-08-23
ApplicantVoco GmbH
Decision Date2022-08-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bifix Hybrid Abutment Cement is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2022-08-23 under approval number K220640. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bifix Hybrid Abutment Cement?
Bifix Hybrid Abutment Cement is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Voco GmbH. The 510(k) number is K220640.
When was Bifix Hybrid Abutment Cement approved by the FDA?
Bifix Hybrid Abutment Cement received FDA 510(k) clearance on 2022-08-23, under approval number K220640.
What company makes Bifix Hybrid Abutment Cement?
Bifix Hybrid Abutment Cement is manufactured by Voco GmbH.
What is the FDA product code for Bifix Hybrid Abutment Cement?
The FDA product code for Bifix Hybrid Abutment Cement is EMA.
Related Clinical Trials
Other Devices by Voco GmbH
Related Devices (Code: EMA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.