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FDA 510(k)

Dentis s-Clean s-Line Mini

K-Number: K210080 · 2021-06-04

ApplicantDentis Co., Ltd.
Decision Date2021-06-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis s-Clean s-Line Mini 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 2021-06-04 under 510(k) number K210080. 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 s-Line Mini?

Dentis s-Clean s-Line Mini is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K210080.

When did Dentis s-Clean s-Line Mini receive FDA 510(k) clearance?

Dentis s-Clean s-Line Mini received FDA 510(k) clearance on 2021-06-04, under 510(k) number K210080.

Who is the listed applicant for Dentis s-Clean s-Line Mini?

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 s-Line Mini?

The FDA product code for Dentis s-Clean s-Line Mini 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.

K253493Dentis SQ-SL AXEL FixtureK241065ChecQ (AC100)K233921Luvis Chair (LC700C)K241063s-Clean ScanHealing AbutmentK240511Dentis s-Clean SQ-SL FixtureK233544MESHEET

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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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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.

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