FDA 510(k)

Renamel Microfill

K-Number: K172707 · 2017-12-05

Decision Date2017-12-05

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Renamel Microfill is a medical device manufactured by Cosmedent, Inc.. It received FDA 510(k) clearance on 2017-12-05 under approval 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. It is manufactured by Cosmedent, Inc.. The 510(k) number is K172707.

When was Renamel Microfill approved by the FDA?

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

What company makes Renamel Microfill?

Renamel Microfill is manufactured by Cosmedent, Inc..

What is the FDA product code for Renamel Microfill?

The FDA product code for Renamel Microfill is EBF.

Other Devices by Cosmedent, Inc.

K163480Renamel NANO +plus K211259Renamel Bulkfill K222435Renamel® Microhybrid ;Renamel® Flowable Microhybrid K240714Insure® Universal; Insure® Universal Automix

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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.