Visalys CemCore, Visalys Cem Core Try In Paste

Q: What is the product code of K191527?

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

FDA 510(k) K191527 · Kettenbach GmbH & Co. KG

Substantially Equivalent

510(k) numberK191527

Submission

Device name: Visalys CemCore, Visalys Cem Core Try In Paste
Applicant: Kettenbach GmbH & Co. KG
Eschenburg, DE
Received: June 10, 2019
Decision date: November 8, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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
K262243	Profisil FreeLBH · Traditional	09/03/2026SE
K250267	Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…EBF · Traditional	03/14/2025SE
K230333	Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint…LBH · Traditional	07/24/2023SE
K191523	Visalys Restorative PrimerKLE · Traditional	10/09/2019SE
K191524	Visalys Tooth PrimerKLE · Traditional	09/29/2019SE
K143104	Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XEBF · Traditional	03/25/2015SE
K122039	Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BEBG · Traditional	12/27/2012SE
K113279	Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…ELW · Special	11/14/2011SE
K092867	Identium Heavy, Medium, Medium Soft, LightELW · Traditional	10/01/2009SE
K083701	Panasil Initial Contact and Panasil TrayELW · Special	01/09/2009SE

Questions and answers

When was Visalys CemCore, Visalys Cem Core Try In Paste cleared by the FDA?

Visalys CemCore, Visalys Cem Core Try In Paste (K191527) received a 510(k) decision of Substantially Equivalent on November 8, 2019, 151 days after the submission was received.

What is the product code of K191527?

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