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FDA 510(k)

SuperLine

K-Number: K213599 · 2022-02-23

Decision Date2022-02-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SuperLine is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K213599. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SuperLine?

SuperLine is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K213599.

When did SuperLine receive FDA 510(k) clearance?

SuperLine received FDA 510(k) clearance on 2022-02-23, under 510(k) number K213599.

Who is the listed applicant for SuperLine?

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

What is the FDA product code for SuperLine?

The FDA product code for SuperLine is DZE.

Other records listing Dentium Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 13 devices →

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.