Ketac-Fil Aplicap Plus

Q: What is the product code of K973262?

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

FDA 510(k) K973262 · Espe GmbH & Co. Kg.

Substantially Equivalent

510(k) numberK973262

Submission

Device name: Ketac-Fil Aplicap Plus
Applicant: Espe GmbH & Co. Kg.
Seefeld, DE
Received: August 29, 1997
Decision date: November 17, 1997
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

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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
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K973513	Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic…EBF · Traditional	12/22/1997SE
K972892	Cavit-LcEBF · Traditional	10/02/1997SE
K963735	Cojet SystemEBF · Traditional	11/27/1996SE
K963737	Hycem AplicapEMA · Traditional	11/15/1996SE
K962428	Ebs (Espe Bonding System)KLE · Traditional	09/12/1996SE
K962442	Hytac Aplitip/Hytac OsbEBF · Traditional	09/11/1996SE
K962440	Pertac Ii/Pertac II AplitipEBF · Traditional	09/11/1996SE
K960954	Ketac-Molar AplicapEMA · Traditional	05/16/1996SE
K960547	Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveELW · Traditional	03/15/1996SE

Questions and answers

When was Ketac-Fil Aplicap Plus cleared by the FDA?

Ketac-Fil Aplicap Plus (K973262) received a 510(k) decision of Substantially Equivalent on November 17, 1997, 80 days after the submission was received.

What is the product code of K973262?

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