Ketac Universal Aplicap

Q: What is the product code of K153174?

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

FDA 510(k) K153174 · 3M Deutschland GmbH

Substantially Equivalent

510(k) numberK153174

Submission

Device name: Ketac Universal Aplicap
Applicant: 3M Deutschland GmbH
Seefeld, DE
Received: November 3, 2015
Decision date: April 13, 2016
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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K252165	Zirconomer PEMA · Traditional	Shofu Dental Corporation	10/28/2025SE

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Questions and answers

When was Ketac Universal Aplicap cleared by the FDA?

Ketac Universal Aplicap (K153174) received a 510(k) decision of Substantially Equivalent on April 13, 2016, 162 days after the submission was received.

What is the product code of K153174?

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