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FDA 510(k)

DX. Bond V Dental Bonding Adhesive

K-Number: K232978 · 2023-09-22

ApplicantSino-Dentex Co., Ltd.
Decision Date2023-09-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DX. Bond V Dental Bonding Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Sino-Dentex Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232978. 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 DX. Bond V Dental Bonding Adhesive?

DX. Bond V Dental Bonding Adhesive is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Sino-Dentex Co., Ltd.. The 510(k) number is K232978.

When did DX. Bond V Dental Bonding Adhesive receive FDA 510(k) clearance?

DX. Bond V Dental Bonding Adhesive received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232978.

Who is the listed applicant for DX. Bond V Dental Bonding Adhesive?

The FDA 510(k) record lists Sino-Dentex Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DX. Bond V Dental Bonding Adhesive?

The FDA product code for DX. Bond V Dental Bonding Adhesive is KLE.

Related Clinical Trials

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.

NCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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