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FDA 510(k)

Renamel Microfill

K-Number: K172707 · 2017-12-05

ApplicantCosmedent, Inc.
Decision Date2017-12-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Renamel Microfill is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2017-12-05 under 510(k) number K172707. 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 Microfill?

Renamel Microfill is a medical device that received FDA 510(k) clearance on 2017-12-05. The listed applicant is Cosmedent, Inc.. The 510(k) number is K172707.

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

Renamel Microfill received FDA 510(k) clearance on 2017-12-05, under 510(k) number K172707.

Who is the listed applicant for Renamel Microfill?

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 Microfill?

The FDA product code for Renamel Microfill 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 BulkfillK163480Renamel 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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