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FDA 510(k)

Warantec Custom Abutment

K-Number: K221972 · 2023-10-02

ApplicantWarantec Co., Ltd.
Decision Date2023-10-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Warantec Custom Abutment is a medical device manufactured by Warantec Co., Ltd.. It received FDA 510(k) clearance on 2023-10-02 under approval number K221972. 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 Warantec Custom Abutment?

Warantec Custom Abutment is a medical device that received FDA 510(k) clearance on 2023-10-02. It is manufactured by Warantec Co., Ltd.. The 510(k) number is K221972.

When was Warantec Custom Abutment approved by the FDA?

Warantec Custom Abutment received FDA 510(k) clearance on 2023-10-02, under approval number K221972.

What company makes Warantec Custom Abutment?

Warantec Custom Abutment is manufactured by Warantec Co., Ltd..

What is the FDA product code for Warantec Custom Abutment?

The FDA product code for Warantec Custom Abutment is NHA.

Other Devices by Warantec Co., Ltd.

K172345IU Implant System K221969IU Implant System Abutment

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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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