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FDA 510(k)

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active

K-Number: K240660 · 2024-09-17

ApplicantKulzer, LLC
Decision Date2024-09-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240660. 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 composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Kulzer, LLC. The 510(k) number is K240660.

When did Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active receive FDA 510(k) clearance?

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240660.

Who is the listed applicant for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

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 composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

The FDA product code for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active 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.

NCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

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 PlusK243910RetraxilK233868dima Print Teeth & TempK230644Signum opaque FK220605Venus 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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