FDA 510(k)

Customized Abutment

K-Number: K223634 · 2023-04-28

Decision Date2023-04-28

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 2023-04-28 under approval number K223634. 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 2023-04-28. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K223634.

When was Customized Abutment approved by the FDA?

Customized Abutment received FDA 510(k) clearance on 2023-04-28, under approval number K223634.

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.

K193425Pre-Milled Blank K210817C&B 5.0 Hybrid K222131NB 1 SA Implant System K213506NB 1 SA Implant System K232560Angled Abutment K230725NB Implant System

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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.