FDA 510(k)

G7, Dental Operative Unit and Accessories

K-Number: K213749 · 2023-04-03

Decision Date2023-04-03

Product CodeEIA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

G7, Dental Operative Unit and Accessories is a medical device manufactured by Shinhung Company, Ltd.. It received FDA 510(k) clearance on 2023-04-03 under approval number K213749. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G7, Dental Operative Unit and Accessories?

G7, Dental Operative Unit and Accessories is a medical device that received FDA 510(k) clearance on 2023-04-03. It is manufactured by Shinhung Company, Ltd.. The 510(k) number is K213749.

When was G7, Dental Operative Unit and Accessories approved by the FDA?

G7, Dental Operative Unit and Accessories received FDA 510(k) clearance on 2023-04-03, under approval number K213749.

What company makes G7, Dental Operative Unit and Accessories?

G7, Dental Operative Unit and Accessories is manufactured by Shinhung Company, Ltd..

What is the FDA product code for G7, Dental Operative Unit and Accessories?

The FDA product code for G7, Dental Operative Unit and Accessories is EIA.

Related Clinical Trials

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Other Devices by Shinhung Company, Ltd.

K151996TAURUS C1

Related Devices (Code: EIA)

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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.