Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect

Q: What is the product code of K082115?

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

FDA 510(k) K082115 · S & C Polymer GmbH

Substantially Equivalent

510(k) numberK082115

Submission

Device name: Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect
Applicant: S & C Polymer GmbH
Elmshorn, DE
Received: July 28, 2008
Decision date: January 15, 2009
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
K091735	DC Provi Cem Esthetic, Esthetic Multi F, ImplantEMA · Traditional	09/25/2009SE
K083062	Root Canal XRKIF · Traditional	03/12/2009SE
K083766	Phoglass CemEMA · Traditional	03/02/2009SE
K081702	Carboxylate Cem, Phosphate CemEMA · Traditional	09/05/2008SE
K042614	S&C-Self Etch Pr-BondKLE · Traditional	11/22/2004SE
K031420	S & C -Bracket AdhesivesDYH · Traditional	08/20/2003SE
K012767	S & C Hydro Vinyl Polysiloxane Impression MaterialELW · Traditional	11/01/2001SE
K011277	Hard RelinerEBI · Traditional	06/26/2001SE
K011431	Resin CemEMA · Traditional	06/11/2001SE
K011064	Classic CemEMA · Traditional	05/17/2001SE

Questions and answers

When was Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect cleared by the FDA?

Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect (K082115) received a 510(k) decision of Substantially Equivalent on January 15, 2009, 171 days after the submission was received.

What is the product code of K082115?

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