FDA 510(k)

CharmFil

K-Number: K193496 · 2020-05-06

Decision Date2020-05-06

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CharmFil is the device name listed in this FDA 510(k) record. The listed applicant is Dentkist, Inc.. It received FDA 510(k) clearance on 2020-05-06 under 510(k) 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. The listed applicant is Dentkist, Inc.. The 510(k) number is K193496.

When did CharmFil receive FDA 510(k) clearance?

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

Who is the listed applicant for CharmFil?

The FDA 510(k) record lists Dentkist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CharmFil?

The FDA product code for CharmFil is EBF.

Other records listing Dentkist, 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.

K152766CharmFlex

Related Devices (Code: EBF)

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual 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.