FDA 510(k)

C-30 Crown Kit

K-Number: K211345 · 2021-11-24

Decision Date2021-11-24

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

C-30 Crown Kit is the device name listed in this FDA 510(k) record. The listed applicant is Perfect Fit Crowns, LLC. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K211345. 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 C-30 Crown Kit?

C-30 Crown Kit is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Perfect Fit Crowns, LLC. The 510(k) number is K211345.

When did C-30 Crown Kit receive FDA 510(k) clearance?

C-30 Crown Kit received FDA 510(k) clearance on 2021-11-24, under 510(k) number K211345.

Who is the listed applicant for C-30 Crown Kit?

The FDA 510(k) record lists Perfect Fit Crowns, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-30 Crown Kit?

The FDA product code for C-30 Crown Kit 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.