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FDA 510(k)

S-Line

K-Number: K182193 · 2019-01-22

ApplicantBiocetec Co., Ltd.
Decision Date2019-01-22
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-Line is a medical device manufactured by Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2019-01-22 under approval number K182193. 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 S-Line?

S-Line is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by Biocetec Co., Ltd.. The 510(k) number is K182193.

When was S-Line approved by the FDA?

S-Line received FDA 510(k) clearance on 2019-01-22, under approval number K182193.

What company makes S-Line?

S-Line is manufactured by Biocetec Co., Ltd..

What is the FDA product code for S-Line?

The FDA product code for S-Line is NJM.

Other Devices by Biocetec Co., Ltd.

K163467C-Line Orthodontic Ceramic Bracket K190871Bio-TackS Orthodontic Mini Implant K231635A-Line Advanced

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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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