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FDA 510(k)

Renamel NANO +plus

K-Number: K163480 · 2017-02-24

ApplicantCosmedent, Inc.
Decision Date2017-02-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Renamel NANO +plus is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K163480. 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 Renamel NANO +plus?

Renamel NANO +plus is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Cosmedent, Inc.. The 510(k) number is K163480.

When did Renamel NANO +plus receive FDA 510(k) clearance?

Renamel NANO +plus received FDA 510(k) clearance on 2017-02-24, under 510(k) number K163480.

Who is the listed applicant for Renamel NANO +plus?

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

What is the FDA product code for Renamel NANO +plus?

The FDA product code for Renamel NANO +plus is EBF.

Other records listing Cosmedent, Inc. 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.

K240714Insure® Universal; Insure® Universal AutomixK222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridK211259Renamel BulkfillK172707Renamel Microfill

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

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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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