SD TL Implant System
FDA 510(k) K242753 · Arum Dentistry Co., Ltd.
510(k) numberK242753
Submission
- Device name
- SD TL Implant System
- Applicant
- Arum Dentistry Co., Ltd.
Daejeon, KR - Received
- September 12, 2024
- Decision date
- January 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
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| 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 |
|---|---|---|
| K250280 | SD TL Implant SystemDZE · Traditional | 07/23/2025SE |
| K250063 | ARENA Star, Galaxy StarEIH · Traditional | 07/10/2025SE |
| K241703 | SD Implant SystemDZE · Traditional | 02/24/2025SE |
| K242245 | Customized AbutmentNHA · Traditional | 11/25/2024SE |
| K232559 | C&B NFH HybridEBF · Traditional | 09/11/2024SE |
| K240603 | Ti-Base & Master FixNHA · Traditional | 06/05/2024SE |
| K234112 | Customized AbutmentNHA · Traditional | 05/09/2024SE |
| K240091 | NB Mini Implant SystemDZE · Traditional | 04/26/2024SE |
| K232560 | Angled AbutmentNHA · Traditional | 12/19/2023SE |
| K230725 | NB Implant SystemDZE · Traditional | 07/01/2023SE |
Questions and answers
When was SD TL Implant System cleared by the FDA?
SD TL Implant System (K242753) received a 510(k) decision of Substantially Equivalent on January 6, 2025, 116 days after the submission was received.
What is the product code of K242753?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.