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FDA 510(k)

PHASEAFILL

K-Number: K782165 · 1979-03-21

ApplicantPhasealloy
Decision Date1979-03-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHASEAFILL is the device name listed in this FDA 510(k) record. The listed applicant is Phasealloy. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K782165. 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 PHASEAFILL?

PHASEAFILL is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Phasealloy. The 510(k) number is K782165.

When did PHASEAFILL receive FDA 510(k) clearance?

PHASEAFILL received FDA 510(k) clearance on 1979-03-21, under 510(k) number K782165.

Who is the listed applicant for PHASEAFILL?

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 PHASEAFILL?

The FDA product code for PHASEAFILL is EBF.

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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.

K830513FIRST TM

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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