Dentis SQ-SL AXEL Fixture— 510(k) K253493

Name: FDA 510(k) clearance K253493
Creator: U.S. Food and Drug Administration
Published: 2026-03-04

Substantially Equivalent

Dentis Co., Ltd.

FDA 510(k) clearance K253493 for Dentis SQ-SL AXEL Fixture, Substantially Equivalent on 2026-03-04. Applicant: Dentis Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dentis Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2025-10-27
Decision date: 2026-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dalseo-Gu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Dentis Co., Ltd.

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K241065 — ChecQ (AC100)2025-03-21
K233921 — Luvis Chair (LC700C)2024-09-06
K241063 — s-Clean ScanHealing Abutment2024-07-25
K240511 — Dentis s-Clean SQ-SL Fixture2024-05-20
K233544 — MESHEET2024-02-22

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.