FDA 510(k)

EsCem

K-Number: K214076 · 2022-12-19

Decision Date2022-12-19

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EsCem is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) 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. The listed applicant is Spident Co., Ltd.. The 510(k) number is K214076.

When did EsCem receive FDA 510(k) clearance?

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

Who is the listed applicant for EsCem?

The FDA 510(k) record lists Spident Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EsCem?

The FDA product code for EsCem is EMA.

Other records listing Spident Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EMA)

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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.