Bifix Hybrid Abutment Cement

Q: What is the product code of K220640?

The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.

FDA 510(k) K220640 · Voco GmbH

Substantially Equivalent

510(k) numberK220640

Submission

Device name: Bifix Hybrid Abutment Cement
Applicant: Voco GmbH
Cuxhaven, DE
Received: March 4, 2022
Decision date: August 23, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EMA – Cement, Dental
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3275
Specialty: Dental

Other 510(k)s with product code EMA

510(k)	Device	Applicant	Decision
K254201	Any-CemEMA · Traditional	Mediclus Co., Ltd.	08/13/2026SE
K261937	PacTemp Automix NEEMA · Traditional	The Belport Company Inc., DBA Gingi-Pak	08/07/2026SE
K261166	Dia-CemEMA · Traditional	DiaDent Group International	07/09/2026SE
K254109	G-Cem UniversalEMA · Traditional	GC America, Inc.	05/18/2026SE
K253337	REGEN Bioactive CementEMA · Traditional	Inter-Med, Inc.	04/15/2026SE
K252606	Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional	Voco GmbH	03/20/2026SE
K254063	iCEM Universal PlusEMA · Abbreviated	Kulzer, LLC	12/19/2025SE
K252785	TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional	Rizhao Huge Biomaterials Company, Ltd.	12/12/2025SE
K252808	GlasIonomer FX-LCEMA · Traditional	Shofu Dental Corporation	12/09/2025SE
K252165	Zirconomer PEMA · Traditional	Shofu Dental Corporation	10/28/2025SE

More from Shofu Dental Corporation

510(k)	Device	Decision
K252073	VOCO Profluorid Varnish + BioMinLBH · Traditional	05/01/2026SE
K261357	Grandio disc multicolorEBF · Traditional	04/27/2026SE
K252606	Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional	03/20/2026SE
K251390	MTA vptKIF · Traditional	07/03/2025SE
K251239	GrandioSO UnlimitedEBF · Special	05/21/2025SE
K231817	AlignerFlow LCDYH · Traditional	12/01/2023SE
K231591	V-Print c&b tempPOW · Traditional	07/31/2023SE
K230877	Admira Fusion 5EBF · Traditional	07/13/2023SE
K220236	V-Print dentbaseEBI · Traditional	09/21/2022SE
K220743	CediTECEBI · Traditional	07/05/2022SE

Questions and answers

When was Bifix Hybrid Abutment Cement cleared by the FDA?

Bifix Hybrid Abutment Cement (K220640) received a 510(k) decision of Substantially Equivalent on August 23, 2022, 172 days after the submission was received.

What is the product code of K220640?

The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.