Cleared Traditional

Dentis SQ-SL AXEL Fixture

K253493 · Dentis Co., Ltd. · Dental
Mar 2026
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K253493 is an FDA 510(k) clearance for the Dentis SQ-SL AXEL Fixture, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dentis Co., Ltd. (Dalseo-Gu, KR). The FDA issued a Cleared decision on March 4, 2026, 128 days after receiving the submission on October 27, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K253493 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2025
Decision Date March 04, 2026
Days to Decision 128 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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