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FDA 510(k)

EDS Universal Cement

K-Number: K152691 · 2016-02-25

ApplicantEssential Dental Systems, Inc.
Decision Date2016-02-25
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EDS Universal Cement is a medical device manufactured by Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2016-02-25 under approval number K152691. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDS Universal Cement?

EDS Universal Cement is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Essential Dental Systems, Inc.. The 510(k) number is K152691.

When was EDS Universal Cement approved by the FDA?

EDS Universal Cement received FDA 510(k) clearance on 2016-02-25, under approval number K152691.

What company makes EDS Universal Cement?

EDS Universal Cement is manufactured by Essential Dental Systems, Inc..

What is the FDA product code for EDS Universal Cement?

The FDA product code for EDS Universal Cement is EMA.

Other Devices by Essential Dental Systems, Inc.

K223340EDS Calculus Softener TURBO CR

Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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