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FDA 510(k)

Dentis SQ-SL AXEL Fixture

K-Number: K253493 · 2026-03-04

ApplicantDentis Co., Ltd.
Decision Date2026-03-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis SQ-SL AXEL 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 2026-03-04 under 510(k) number K253493. 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 SQ-SL AXEL Fixture?

Dentis SQ-SL AXEL Fixture is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K253493.

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

Dentis SQ-SL AXEL Fixture received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253493.

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

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

Other records listing Dentis Co., Ltd. as applicant

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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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