FDA 510(k)

Charisma

K-Number: K160049 · 2016-11-15

ApplicantHeraeus Kulzer, LLC (Mitsui Chemicals Group)

Decision Date2016-11-15

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Charisma is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC (Mitsui Chemicals Group). It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160049. 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 Charisma?

Charisma is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Heraeus Kulzer, LLC (Mitsui Chemicals Group). The 510(k) number is K160049.

When did Charisma receive FDA 510(k) clearance?

Charisma received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160049.

Who is the listed applicant for Charisma?

The FDA 510(k) record lists Heraeus Kulzer, LLC (Mitsui Chemicals Group) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Charisma?

The FDA product code for Charisma is EBF.

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 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.