FDA 510(k)

Orthodontic Acrylic 2

Número K: K163482 · 2017-05-31

RequerenteLang Dental Manufacturing Co., Inc.

Data da decisão2017-05-31

Código do produtoEBI

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Orthodontic Acrylic 2 is the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K163482. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Orthodontic Acrylic 2?

Orthodontic Acrylic 2 is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Lang Dental Manufacturing Co., Inc.. The 510(k) number is K163482.

When did Orthodontic Acrylic 2 receive FDA 510(k) clearance?

Orthodontic Acrylic 2 received FDA 510(k) clearance on 2017-05-31, under 510(k) number K163482.

Who is the listed applicant for Orthodontic Acrylic 2?

The FDA 510(k) record lists Lang Dental Manufacturing Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthodontic Acrylic 2?

The FDA product code for Orthodontic Acrylic 2 is EBI.

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