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FDA 510(k)

Dentis s-Clean Regular Abutment

K-Number: K230126 · 2023-08-04

Decision Date2023-08-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis s-Clean Regular Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K230126. 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 s-Clean Regular Abutment?

Dentis s-Clean Regular Abutment is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K230126.

When did Dentis s-Clean Regular Abutment receive FDA 510(k) clearance?

Dentis s-Clean Regular Abutment received FDA 510(k) clearance on 2023-08-04, under 510(k) number K230126.

Who is the listed applicant for Dentis s-Clean Regular Abutment?

The FDA 510(k) record lists Dentis Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentis s-Clean Regular Abutment?

The FDA product code for Dentis s-Clean Regular Abutment is NHA.

Other records listing Dentis Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 31 devices →

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.