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FDA 510(k)

BeautiLink SA

K-Number: K233161 · 2023-09-28

ApplicantShofu Dental Corporation
Decision Date2023-09-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BeautiLink 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 2023-09-28 under 510(k) number K233161. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BeautiLink SA?

BeautiLink SA is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Shofu Dental Corporation. The 510(k) number is K233161.

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

BeautiLink SA received FDA 510(k) clearance on 2023-09-28, under 510(k) number K233161.

Who is the listed applicant for BeautiLink 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 BeautiLink SA?

The FDA product code for BeautiLink SA is EMA.

Other records listing Shofu Dental Corporation as applicant

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Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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