FDA 510(k)

Bioliner

Número K: K182658 · 2019-06-19

RequerenteFive Star Orthodontic Lab & Supply

Data da decisão2019-06-19

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bioliner is the device name listed in this FDA 510(k) record. The listed applicant is Five Star Orthodontic Lab & Supply. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182658. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bioliner?

Bioliner is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Five Star Orthodontic Lab & Supply. The 510(k) number is K182658.

When did Bioliner receive FDA 510(k) clearance?

Bioliner received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182658.

Who is the listed applicant for Bioliner?

The FDA 510(k) record lists Five Star Orthodontic Lab & Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioliner?

The FDA product code for Bioliner is NXC.

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