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FDA 510(k)

EZ Bond Universal

K-Number: K230009 · 2023-03-03

ApplicantMeta Biomed Co., Ltd.
Decision Date2023-03-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EZ Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230009. 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 EZ Bond Universal?

EZ Bond Universal is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K230009.

When did EZ Bond Universal receive FDA 510(k) clearance?

EZ Bond Universal received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230009.

Who is the listed applicant for EZ Bond Universal?

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

What is the FDA product code for EZ Bond Universal?

The FDA product code for EZ Bond Universal is KLE.

Other records listing Meta Biomed Co., Ltd. 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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