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FDA 510(k)

ISO Abutment

K-Number: K241183 · 2025-07-28

ApplicantSeum Medi Co., Ltd.
Decision Date2025-07-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ISO Abutment is a medical device manufactured by Seum Medi Co., Ltd.. It received FDA 510(k) clearance on 2025-07-28 under approval number K241183. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISO Abutment?

ISO Abutment is a medical device that received FDA 510(k) clearance on 2025-07-28. It is manufactured by Seum Medi Co., Ltd.. The 510(k) number is K241183.

When was ISO Abutment approved by the FDA?

ISO Abutment received FDA 510(k) clearance on 2025-07-28, under approval number K241183.

What company makes ISO Abutment?

ISO Abutment is manufactured by Seum Medi Co., Ltd..

What is the FDA product code for ISO Abutment?

The FDA product code for ISO Abutment is NHA.

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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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