FDA 510(k)

Dentis I-FIX Abutment

K-Number: K230203 · 2023-05-03

Decision Date2023-05-03

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Dentis I-FIX Abutment is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-05-03 under approval number K230203. 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 Dentis I-FIX Abutment?

Dentis I-FIX Abutment is a medical device that received FDA 510(k) clearance on 2023-05-03. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K230203.

When was Dentis I-FIX Abutment approved by the FDA?

Dentis I-FIX Abutment received FDA 510(k) clearance on 2023-05-03, under approval number K230203.

What company makes Dentis I-FIX Abutment?

Dentis I-FIX Abutment is manufactured by Dentis Co., Ltd..

What is the FDA product code for Dentis I-FIX Abutment?

The FDA product code for Dentis I-FIX 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.