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FDA 510(k)

Signum opaque F

K-Number: K230644 · 2023-09-07

ApplicantKulzer, LLC
Decision Date2023-09-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Signum opaque F is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K230644. 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 Signum opaque F?

Signum opaque F is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Kulzer, LLC. The 510(k) number is K230644.

When did Signum opaque F receive FDA 510(k) clearance?

Signum opaque F received FDA 510(k) clearance on 2023-09-07, under 510(k) number K230644.

Who is the listed applicant for Signum opaque F?

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

What is the FDA product code for Signum opaque F?

The FDA product code for Signum opaque F is EBF.

Other records listing Kulzer, LLC 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.

K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneK254063iCEM Universal PlusK243910RetraxilK240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeK233868dima Print Teeth & TempK220605Venus Bulk Flow ONE

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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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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