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FDA 510(k)

Renamel® Microhybrid ;Renamel® Flowable Microhybrid

K-Number: K222435 · 2022-10-11

ApplicantCosmedent, Inc.
Decision Date2022-10-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Renamel® Microhybrid ;Renamel® Flowable Microhybrid is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K222435. 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® Microhybrid ;Renamel® Flowable Microhybrid?

Renamel® Microhybrid ;Renamel® Flowable Microhybrid is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Cosmedent, Inc.. The 510(k) number is K222435.

When did Renamel® Microhybrid ;Renamel® Flowable Microhybrid receive FDA 510(k) clearance?

Renamel® Microhybrid ;Renamel® Flowable Microhybrid received FDA 510(k) clearance on 2022-10-11, under 510(k) number K222435.

Who is the listed applicant for Renamel® Microhybrid ;Renamel® Flowable Microhybrid?

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® Microhybrid ;Renamel® Flowable Microhybrid?

The FDA product code for Renamel® Microhybrid ;Renamel® Flowable Microhybrid 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 AutomixK211259Renamel BulkfillK172707Renamel MicrofillK163480Renamel NANO +plus

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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