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FDA 510(k)

FIRST TM

K-Number: K830513 · 1983-05-09

ApplicantPhasealloy
Decision Date1983-05-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIRST TM is the device name listed in this FDA 510(k) record. The listed applicant is Phasealloy. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K830513. 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 FIRST TM?

FIRST TM is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Phasealloy. The 510(k) number is K830513.

When did FIRST TM receive FDA 510(k) clearance?

FIRST TM received FDA 510(k) clearance on 1983-05-09, under 510(k) number K830513.

Who is the listed applicant for FIRST TM?

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

What is the FDA product code for FIRST TM?

The FDA product code for FIRST TM is EBF.

Related Clinical Trials

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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Other records listing Phasealloy 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.

K782165PHASEAFILL

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

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

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