FDA 510(k)

BIJOU Orthodontic Ceramic Bracket

Número K: K152167 · 2016-05-27

Data da decisão2016-05-27

Código do produtoNJM

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BIJOU Orthodontic Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is World Bio Tech Co., Ltd.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K152167. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BIJOU Orthodontic Ceramic Bracket?

BIJOU Orthodontic Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is World Bio Tech Co., Ltd.. The 510(k) number is K152167.

When did BIJOU Orthodontic Ceramic Bracket receive FDA 510(k) clearance?

BIJOU Orthodontic Ceramic Bracket received FDA 510(k) clearance on 2016-05-27, under 510(k) number K152167.

Who is the listed applicant for BIJOU Orthodontic Ceramic Bracket?

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

What is the FDA product code for BIJOU Orthodontic Ceramic Bracket?

The FDA product code for BIJOU Orthodontic Ceramic Bracket is NJM.

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