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FDA 510(k)

EsCem RMGI

K-Number: K250566 · 2025-06-20

ApplicantSpident Co., Ltd.
Decision Date2025-06-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EsCem RMGI 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 2025-06-20 under 510(k) number K250566. 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 RMGI?

EsCem RMGI is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Spident Co., Ltd.. The 510(k) number is K250566.

When did EsCem RMGI receive FDA 510(k) clearance?

EsCem RMGI received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250566.

Who is the listed applicant for EsCem RMGI?

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 RMGI?

The FDA product code for EsCem RMGI 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)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-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.

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