Admira Fusion x-tra

Q: What is the product code of K151956?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.

FDA 510(k) K151956 · Voco GmbH

Substantially Equivalent

510(k) numberK151956

Submission

Device name: Admira Fusion x-tra
Applicant: Voco GmbH
Cuxhaven, DE
Received: July 15, 2015
Decision date: October 20, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EBF – Material, Tooth Shade, Resin
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3690
Specialty: Dental

Other 510(k)s with product code EBF

510(k)	Device	Applicant	Decision
K262202	Cerasmart ForteEBF · Traditional	GC America, Inc.	09/10/2026SE
K261695	Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional	Guilin Kevin Peter Technology Co., Ltd.	08/31/2026SE
K262228	Transcend Bulk Fill Flowable CompositeEBF · Traditional	Ultradent Products, Inc.	07/01/2026SE
K261485	Tetric plus Fill;Tetric plus FlowEBF · Traditional	Ivoclar Vivadent, Inc.	07/01/2026SE
K261246	SRGC-06EBF · Traditional	GC America, Inc.	06/18/2026SE
K261093	DiafilEBF · Traditional	DiaDent Group International	06/02/2026SE
K261071	DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional	DiaDent Group International	05/19/2026SE
K260805	Dual CoreEBF · Traditional	Vericom Co., Ltd.	05/11/2026SE
K261357	Grandio disc multicolorEBF · Traditional	Voco GmbH	04/27/2026SE
K261356	Dura-CrownEBF · Special	Hangzhou SHINING3D Dental Technology Co., Ltd.	04/27/2026SE

More from Hangzhou SHINING3D Dental Technology Co., Ltd.

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
K220640	Bifix Hybrid Abutment CementEMA · Traditional	08/23/2022SE

Questions and answers

When was Admira Fusion x-tra cleared by the FDA?

Admira Fusion x-tra (K151956) received a 510(k) decision of Substantially Equivalent on October 20, 2015, 97 days after the submission was received.

What is the product code of K151956?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.