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FDA 510(k)

Dia-X Bond Universal

K-Number: K220804 · 2022-06-15

ApplicantDiaDent Group International
Decision Date2022-06-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dia-X Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K220804. 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 Dia-X Bond Universal?

Dia-X Bond Universal is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is DiaDent Group International. The 510(k) number is K220804.

When did Dia-X Bond Universal receive FDA 510(k) clearance?

Dia-X Bond Universal received FDA 510(k) clearance on 2022-06-15, under 510(k) number K220804.

Who is the listed applicant for Dia-X Bond Universal?

The FDA 510(k) record lists DiaDent Group International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dia-X Bond Universal?

The FDA product code for Dia-X Bond Universal is KLE.

Other records listing DiaDent Group International 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.

K261166DIA-CEMK261093DIAFILK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)K254112Dia-X Sil BiteK231552Dia-CemK213401DIAPLUS Universal

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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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