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FDA 510(k)

Dia-Cem

K-Number: K231552 · 2023-07-28

ApplicantDiaDent Group International
Decision Date2023-07-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dia-Cem is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2023-07-28 under approval number K231552. 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 Dia-Cem?

Dia-Cem is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by DiaDent Group International. The 510(k) number is K231552.

When was Dia-Cem approved by the FDA?

Dia-Cem received FDA 510(k) clearance on 2023-07-28, under approval number K231552.

What company makes Dia-Cem?

Dia-Cem is manufactured by DiaDent Group International.

What is the FDA product code for Dia-Cem?

The FDA product code for Dia-Cem is EMA.

Other Devices by DiaDent Group International

K182009Dia-Proseal K182625Diapex Plus K200174DIA-ROOT BIO MTA K200809D-LUX+ K200175DIA-ROOT BIO Sealer K192392DiaPlus

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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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