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FDA 510(k)

Fit SA

K-Number: K182869 · 2019-01-09

ApplicantShofu Dental Corporation
Decision Date2019-01-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fit SA is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K182869. 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 Fit SA?

Fit SA is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Shofu Dental Corporation. The 510(k) number is K182869.

When did Fit SA receive FDA 510(k) clearance?

Fit SA received FDA 510(k) clearance on 2019-01-09, under 510(k) number K182869.

Who is the listed applicant for Fit SA?

The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fit SA?

The FDA product code for Fit SA is EBF.

Other records listing Shofu Dental Corporation as applicant

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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 InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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