MegaGen Zygoma Dental Implant System
FDA 510(k) K251232 · Megagen Implant Co., Ltd.
510(k) numberK251232
Submission
- Device name
- MegaGen Zygoma Dental Implant System
- Applicant
- Megagen Implant Co., Ltd.
Deagu, KR - Received
- April 22, 2025
- Decision date
- June 18, 2026
- 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 |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| 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 |
| K252197 | Nobel Biocare S Series ImplantsDZE · Traditional | Nobel Biocare AB | 02/18/2026SE |
More from Nobel Biocare AB
| 510(k) | Device | Decision |
|---|---|---|
| K242030 | MegaGen Dental Implant AbutmentNHA · Traditional | 01/13/2025SE |
| K241972 | Bluediamond ImplantDZE · Traditional | 12/27/2024SE |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentNHA · Traditional | 09/18/2024SE |
| K240754 | N2EIA · Special | 03/21/2024SE |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…NHA · Traditional | 01/22/2024SE |
| K231967 | ARi ExCon Implant SystemDZE · Traditional | 12/07/2023SE |
| K223909 | R2GATE Lite TMLLZ · Traditional | 10/20/2023SE |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional | 10/11/2023SE |
| K223339 | Bone Chamber ImplantDZE · Traditional | 07/18/2023SE |
| K211556 | N2EIA · Traditional | 04/05/2023SE |
Questions and answers
When was MegaGen Zygoma Dental Implant System cleared by the FDA?
MegaGen Zygoma Dental Implant System (K251232) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 422 days after the submission was received.
What is the product code of K251232?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.