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FDA 510(k)

CharmFil

K-Number: K193496 · 2020-05-06

ApplicantDentkist, Inc.
Decision Date2020-05-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CharmFil is a medical device manufactured by Dentkist, Inc.. It received FDA 510(k) clearance on 2020-05-06 under approval number K193496. 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 CharmFil?

CharmFil is a medical device that received FDA 510(k) clearance on 2020-05-06. It is manufactured by Dentkist, Inc.. The 510(k) number is K193496.

When was CharmFil approved by the FDA?

CharmFil received FDA 510(k) clearance on 2020-05-06, under approval number K193496.

What company makes CharmFil?

CharmFil is manufactured by Dentkist, Inc..

What is the FDA product code for CharmFil?

The FDA product code for CharmFil is EBF.

Other Devices by Dentkist, Inc.

K152766CharmFlex

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

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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