Dentis SQ-SL AXEL Fixture
FDA 510(k) K253493 · Dentis Co., Ltd.
510(k) numberK253493
Submission
- Device name
- Dentis SQ-SL AXEL Fixture
- Applicant
- Dentis Co., Ltd.
Dalseo-Gu, KR - Received
- October 27, 2025
- Decision date
- March 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
| K260006 | INOSS SystemDZE · Traditional | Inosys, Inc. | 06/17/2026SE |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
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| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
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| K240511 | Dentis s-Clean SQ-SL FixtureDZE · Traditional | 05/20/2024SE |
| K233544 | MesheetNXC · Traditional | 02/22/2024SE |
| K230126 | Dentis s-Clean Regular AbutmentNHA · Traditional | 08/04/2023SE |
| K230307 | Dentis i-Clean SystemNHA · Traditional | 07/11/2023SE |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional | 05/25/2023SE |
| K230523 | s-Clean Link Abutment NarrowNHA · Traditional | 05/24/2023SE |
| K230203 | Dentis I-FIX AbutmentNHA · Traditional | 05/03/2023SE |
Questions and answers
When was Dentis SQ-SL AXEL Fixture cleared by the FDA?
Dentis SQ-SL AXEL Fixture (K253493) received a 510(k) decision of Substantially Equivalent on March 4, 2026, 128 days after the submission was received.
What is the product code of K253493?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.