Dentis i-Clean System
K-Number: K230307 · 2023-07-11
Device Summary
Frequently Asked Questions
What is the Dentis i-Clean System?
Dentis i-Clean System is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K230307.
When did Dentis i-Clean System receive FDA 510(k) clearance?
Dentis i-Clean System received FDA 510(k) clearance on 2023-07-11, under 510(k) number K230307.
Who is the listed applicant for Dentis i-Clean System?
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 i-Clean System?
The FDA product code for Dentis i-Clean System 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.