Guided Bone Regeneration System
FDA 510(k) K254286 · DentalMaster(Xiamen)Medical Technology Co., Ltd.
510(k) numberK254286
Submission
- Device name
- Guided Bone Regeneration System
- Applicant
- DentalMaster(Xiamen)Medical Technology Co., Ltd.
Xiamen, CN - Received
- December 31, 2025
- Decision date
- August 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)DZL · Traditional | Hager& Meisinger GmbH | 09/29/2025SE |
| K251569 | Bone ScrewDZL · Traditional | Osstem Implant Co., Ltd. | 08/13/2025SE |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PINDZL · Traditional | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 06/27/2025SE |
| K233419 | GBR SystemDZL · Traditional | Proimtech Saglik Urunleri Anonim Sirketi | 01/03/2025SE |
| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | Hager& Meisinger GmbH | 10/17/2024SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | KLS-Martin L.P. | 09/17/2024SE |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL · Traditional | Stryker Leibinger GmbH & Co KG | 08/24/2023SE |
| K222367 | Save GBRDZL · Traditional | Dentis Co., Ltd. | 03/23/2023SE |
| K201210 | The Micro Screw System, Micro Screw System BasicDZL · Traditional | Hager& Meisinger GmbH | 10/08/2021SE |
| K201561 | Membrane Screws and Membrane TacksDZL · Traditional | Neoss Limited | 10/05/2020SE |
Questions and answers
When was Guided Bone Regeneration System cleared by the FDA?
Guided Bone Regeneration System (K254286) received a 510(k) decision of Substantially Equivalent on August 24, 2026, 236 days after the submission was received.
What is the product code of K254286?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.