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FDA 510(k)

ESCOM 100

K-Number: K110428 · 2011-02-25

ApplicantSpident Co., Ltd.
Decision Date2011-02-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESCOM 100 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 2011-02-25 under 510(k) number K110428. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCOM 100?

ESCOM 100 is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Spident Co., Ltd.. The 510(k) number is K110428.

When did ESCOM 100 receive FDA 510(k) clearance?

ESCOM 100 received FDA 510(k) clearance on 2011-02-25, under 510(k) number K110428.

Who is the listed applicant for ESCOM 100?

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 ESCOM 100?

The FDA product code for ESCOM 100 is EBF.

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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: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC 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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