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FDA 510(k)

BeautiBond Universal

K-Number: K180803 · 2018-09-26

ApplicantShofu Dental Corporation
Decision Date2018-09-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BeautiBond Universal 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 2018-09-26 under 510(k) number K180803. 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 Universal?

BeautiBond Universal is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Shofu Dental Corporation. The 510(k) number is K180803.

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

BeautiBond Universal received FDA 510(k) clearance on 2018-09-26, under 510(k) number K180803.

Who is the listed applicant for BeautiBond Universal?

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 Universal?

The FDA product code for BeautiBond Universal is KLE.

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.

K252808GlasIonomer FX-LCK252165ZIRCONOMER PK251470ResiCem EXK251578BEAUTIFIL IIK233161BeautiLink SAK222253GlasIonomer FX ULTRA

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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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