FDA 510(k)

TEMP IT

K-Number: K100413 · 2010-03-03

Decision Date2010-03-03

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TEMP IT 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 2010-03-03 under 510(k) number K100413. 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 TEMP IT?

TEMP IT is a medical device that received FDA 510(k) clearance on 2010-03-03. The listed applicant is Spident Co., Ltd.. The 510(k) number is K100413.

When did TEMP IT receive FDA 510(k) clearance?

TEMP IT received FDA 510(k) clearance on 2010-03-03, under 510(k) number K100413.

Who is the listed applicant for TEMP IT?

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 TEMP IT?

The FDA product code for TEMP IT is EBF.

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: EBF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.