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FDA 510(k)

Healing Abutments and Cover Screws

K-Number: K192436 · 2020-01-23

Decision Date2020-01-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Healing Abutments and Cover Screws is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2020-01-23 under approval number K192436. 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 Healing Abutments and Cover Screws?

Healing Abutments and Cover Screws is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K192436.

When was Healing Abutments and Cover Screws approved by the FDA?

Healing Abutments and Cover Screws received FDA 510(k) clearance on 2020-01-23, under approval number K192436.

What company makes Healing Abutments and Cover Screws?

Healing Abutments and Cover Screws is manufactured by Dentium Co., Ltd..

What is the FDA product code for Healing Abutments and Cover Screws?

The FDA product code for Healing Abutments and Cover Screws is NHA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.