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FDA 510(k)

BIJOU Orthodontic Ceramic Bracket

K-Number: K152167 · 2016-05-27

ApplicantWorld Bio Tech Co., Ltd.
Decision Date2016-05-27
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by World Bio Tech Co., Ltd.. The 510(k) number is K152167.

When was BIJOU Orthodontic Ceramic Bracket approved by the FDA?

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

What company makes BIJOU Orthodontic Ceramic Bracket?

BIJOU Orthodontic Ceramic Bracket is manufactured by World Bio Tech Co., Ltd..

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

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

Related Clinical Trials

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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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