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FDA 510(k)

C-Line Orthodontic Ceramic Bracket

K-Number: K163467 · 2017-06-14

ApplicantBiocetec Co., Ltd.
Decision Date2017-06-14
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C-Line Orthodontic Ceramic Bracket is a medical device manufactured by Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2017-06-14 under approval number K163467. 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 C-Line Orthodontic Ceramic Bracket?

C-Line Orthodontic Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2017-06-14. It is manufactured by Biocetec Co., Ltd.. The 510(k) number is K163467.

When was C-Line Orthodontic Ceramic Bracket approved by the FDA?

C-Line Orthodontic Ceramic Bracket received FDA 510(k) clearance on 2017-06-14, under approval number K163467.

What company makes C-Line Orthodontic Ceramic Bracket?

C-Line Orthodontic Ceramic Bracket is manufactured by Biocetec Co., Ltd..

What is the FDA product code for C-Line Orthodontic Ceramic Bracket?

The FDA product code for C-Line Orthodontic Ceramic Bracket is NJM.

Related Clinical Trials

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Other Devices by Biocetec Co., Ltd.

K182193S-Line K190871Bio-TackS Orthodontic Mini Implant K231635A-Line Advanced

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163117Alpha PureKoroad America K181271Signature Orthodontic SystemSignature Orthodontics

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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