FDA 510(k)

Customized Abutment

K-Number: K242245 · 2024-11-25

Decision Date2024-11-25

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Customized Abutment is a medical device manufactured by Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2024-11-25 under approval number K242245. 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 Customized Abutment?

Customized Abutment is a medical device that received FDA 510(k) clearance on 2024-11-25. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K242245.

When was Customized Abutment approved by the FDA?

Customized Abutment received FDA 510(k) clearance on 2024-11-25, under approval number K242245.

What company makes Customized Abutment?

Customized Abutment is manufactured by Arum Dentistry Co., Ltd..

What is the FDA product code for Customized Abutment?

The FDA product code for Customized Abutment is NHA.

Other Devices by Arum Dentistry Co., Ltd.

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Related Devices (Code: 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.