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FDA 510(k)

UNO

K-Number: K071131 · 2007-07-25

Applicant3M Espe AG Dental Products
Decision Date2007-07-25
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNO is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe AG Dental Products. It received FDA 510(k) clearance on 2007-07-25 under 510(k) number K071131. 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 UNO?

UNO is a medical device that received FDA 510(k) clearance on 2007-07-25. The listed applicant is 3M Espe AG Dental Products. The 510(k) number is K071131.

When did UNO receive FDA 510(k) clearance?

UNO received FDA 510(k) clearance on 2007-07-25, under 510(k) number K071131.

Who is the listed applicant for UNO?

The FDA 510(k) record lists 3M Espe AG Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNO?

The FDA product code for UNO is KLE.

Related PubMed Literature

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.

PMID: 33050694Unravelling the Immunotoxicity of Polycaprolactone Nanoparticles-Effects of Polymer Molecular Weight, Hydrolysis, and Blends.Chemical research in toxicology ()

Other records listing 3M Espe AG Dental Products 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.

K100908UNICEM HMK100756MALTAK094007UNICEMK093721COSP2K091826ELEGANTK090718BELLUS SHADING KIT

View all 24 devices →

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-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.

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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