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FDA 510(k)

EsCem

K-Number: K214076 · 2022-12-19

ApplicantSpident Co., Ltd.
Decision Date2022-12-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EsCem is a medical device manufactured by Spident Co., Ltd.. It received FDA 510(k) clearance on 2022-12-19 under approval number K214076. 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 EsCem?

EsCem is a medical device that received FDA 510(k) clearance on 2022-12-19. It is manufactured by Spident Co., Ltd.. The 510(k) number is K214076.

When was EsCem approved by the FDA?

EsCem received FDA 510(k) clearance on 2022-12-19, under approval number K214076.

What company makes EsCem?

EsCem is manufactured by Spident Co., Ltd..

What is the FDA product code for EsCem?

The FDA product code for EsCem is EMA.

Other Devices by Spident Co., Ltd.

K161774i-Sil K214071Hexa-Temp K231523EsCom250 K242702VioSeal K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) K241445K-Bond Universal

View all 9 devices →

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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