Cement It! Universal C&B

Q: What is the product code of K000173?

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

FDA 510(k) K000173 · Jeneric/Pentron, Inc.

Substantially Equivalent

510(k) numberK000173

Submission

Device name: Cement It! Universal C&B
Applicant: Jeneric/Pentron, Inc.
Wallingford, CT, US
Received: January 20, 2000
Decision date: February 29, 2000
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

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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

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K012231	Avante Micro Crystal SystemEIH · Traditional	08/23/2001SE
K011748	First Fill R.C.S.KIF · Traditional	08/03/2001SE
K010957	Quell DesensitizerLBH · Traditional	06/25/2001SE
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K011330	JP Cast 50EJT · Traditional	06/22/2001SE
K011362	Gold Core 73 LSEJT · Traditional	05/29/2001SE
K010044	CosmicEJT · Traditional	02/09/2001SE

Questions and answers

When was Cement It! Universal C&B cleared by the FDA?

Cement It! Universal C&B (K000173) received a 510(k) decision of Substantially Equivalent on February 29, 2000, 40 days after the submission was received.

What is the product code of K000173?

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