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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 a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2023-09-28 under approval 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. It is manufactured by Shofu Dental Corporation. The 510(k) number is K233161.

When was BeautiLink SA approved by the FDA?

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

What company makes BeautiLink SA?

BeautiLink SA is manufactured by Shofu Dental Corporation.

What is the FDA product code for BeautiLink SA?

The FDA product code for BeautiLink SA is EMA.

Other Devices by Shofu Dental Corporation

K161891HC Primer K160596BEAUTIFIL II LS K160086SHOFU Enamel Conditioner K151700BEAUTIFIL II Gingiva K152392VINTAGE LD K172530BEAUTIFIL Flow Plus X

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Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

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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