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FDA 510(k)

Renamel Bulkfill

K-Number: K211259 · 2021-06-24

ApplicantCosmedent, Inc.
Decision Date2021-06-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Renamel Bulkfill is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K211259. 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 Bulkfill?

Renamel Bulkfill is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Cosmedent, Inc.. The 510(k) number is K211259.

When did Renamel Bulkfill receive FDA 510(k) clearance?

Renamel Bulkfill received FDA 510(k) clearance on 2021-06-24, under 510(k) number K211259.

Who is the listed applicant for Renamel Bulkfill?

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 Bulkfill?

The FDA product code for Renamel Bulkfill 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 MicrohybridK172707Renamel 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

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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