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FDA 510(k)

Novidia Universal Bond

K-Number: K183391 · 2019-09-24

ApplicantNobio , Ltd.
Decision Date2019-09-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Novidia Universal Bond is the device name listed in this FDA 510(k) record. The listed applicant is Nobio , Ltd.. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K183391. 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 Novidia Universal Bond?

Novidia Universal Bond is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Nobio , Ltd.. The 510(k) number is K183391.

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

Novidia Universal Bond received FDA 510(k) clearance on 2019-09-24, under 510(k) number K183391.

Who is the listed applicant for Novidia Universal Bond?

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

What is the FDA product code for Novidia Universal Bond?

The FDA product code for Novidia Universal Bond is KLE.

Other records listing Nobio , 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.

K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeK182921Infinix Universal CompositeK182714Novidia Bulk Fill Flow CompositeK182580Novidia Flowable Composite

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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