Dentis s-Clean s-Line Mini
FDA 510(k) K210080 · Dentis Co., Ltd.
510(k) numberK210080
Submission
- Device name
- Dentis s-Clean s-Line Mini
- Applicant
- Dentis Co., Ltd.
Daegu, KR - Received
- January 12, 2021
- Decision date
- June 4, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| 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 |
| K253334 | ZENEX Implant System_Short (R-System)DZE · Traditional | Izenimplant Co., Ltd. | 03/16/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | 03/04/2026SE |
| K241065 | ChecQ (AC100)EKX · Traditional | 03/21/2025SE |
| K233921 | Luvis Chair (LC700C)KLC · Traditional | 09/06/2024SE |
| K241063 | s-Clean ScanHealing AbutmentNHA · Traditional | 07/25/2024SE |
| 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 |
Questions and answers
When was Dentis s-Clean s-Line Mini cleared by the FDA?
Dentis s-Clean s-Line Mini (K210080) received a 510(k) decision of Substantially Equivalent on June 4, 2021, 143 days after the submission was received.
What is the product code of K210080?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.