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FDA 510(k)

Stella

K-Number: K221752 · 2023-06-04

ApplicantShinhung Mst Co., Ltd.
Decision Date2023-06-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stella is a medical device manufactured by Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2023-06-04 under approval number K221752. 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 Stella?

Stella is a medical device that received FDA 510(k) clearance on 2023-06-04. It is manufactured by Shinhung Mst Co., Ltd.. The 510(k) number is K221752.

When was Stella approved by the FDA?

Stella received FDA 510(k) clearance on 2023-06-04, under approval number K221752.

What company makes Stella?

Stella is manufactured by Shinhung Mst Co., Ltd..

What is the FDA product code for Stella?

The FDA product code for Stella is DZE.

Other Devices by Shinhung Mst Co., Ltd.

K160106LUNA DENTAL IMPLANT SYSTEM K162867MagDen Dental Implant System K200189Luna Dental Implant System- Healing Abutment K223395Luna Dental Implant System K221317S-Mono

Related Devices (Code: DZE)

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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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