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FDA 510(k)

Dentis s-Clean SQ-SL Fixture

K-Number: K240511 · 2024-05-20

Decision Date2024-05-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis s-Clean SQ-SL Fixture 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 2024-05-20 under 510(k) number K240511. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentis s-Clean SQ-SL Fixture?

Dentis s-Clean SQ-SL Fixture is a medical device that received FDA 510(k) clearance on 2024-05-20. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K240511.

When did Dentis s-Clean SQ-SL Fixture receive FDA 510(k) clearance?

Dentis s-Clean SQ-SL Fixture received FDA 510(k) clearance on 2024-05-20, under 510(k) number K240511.

Who is the listed applicant for Dentis s-Clean SQ-SL Fixture?

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 SQ-SL Fixture?

The FDA product code for Dentis s-Clean SQ-SL Fixture is DZE.

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: DZE)

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.