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FDA 510(k)

BeautiBond Xtreme

K-Number: K213965 · 2022-03-18

ApplicantShofu Dental Corporation
Decision Date2022-03-18
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BeautiBond Xtreme 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 2022-03-18 under 510(k) number K213965. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BeautiBond Xtreme?

BeautiBond Xtreme is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Shofu Dental Corporation. The 510(k) number is K213965.

When did BeautiBond Xtreme receive FDA 510(k) clearance?

BeautiBond Xtreme received FDA 510(k) clearance on 2022-03-18, under 510(k) number K213965.

Who is the listed applicant for BeautiBond Xtreme?

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 BeautiBond Xtreme?

The FDA product code for BeautiBond Xtreme is KLE.

Related Clinical Trials

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NCT07731061Clinical Performance of Two HEMA-Free Universal Adhesive SystemsNOT_YET_RECRUITING

Other records listing Shofu Dental Corporation as applicant

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.

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Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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