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FDA 510(k)

ESTEMP NE

K-Number: K100290 · 2010-02-17

ApplicantSpident Co., Ltd.
Decision Date2010-02-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTEMP NE 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 2010-02-17 under 510(k) number K100290. 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 ESTEMP NE?

ESTEMP NE is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Spident Co., Ltd.. The 510(k) number is K100290.

When did ESTEMP NE receive FDA 510(k) clearance?

ESTEMP NE received FDA 510(k) clearance on 2010-02-17, under 510(k) number K100290.

Who is the listed applicant for ESTEMP NE?

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 ESTEMP NE?

The FDA product code for ESTEMP NE is EMA.

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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.

K262983EsTemp ImplantK262982Core·it DualK262050Vioseal XK261129OrthoFitK250566EsCem RMGIK250317EsFlow PLUS

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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.

K262983EsTemp ImplantSpident Co., Ltd.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.

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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