MP Pin flat without thread (36BMP000020/MP20)
FDA 510(k) K240321 · Hager& Meisinger GmbH
510(k) numberK240321
Submission
- Device name
- MP Pin flat without thread (36BMP000020/MP20)
- Applicant
- Hager& Meisinger GmbH
Neuss, DE - Received
- February 2, 2024
- Decision date
- October 17, 2024
- 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 |
|---|---|---|---|
| K254286 | Guided Bone Regeneration SystemDZL · Traditional | DentalMaster(Xiamen)Medical Technology Co., Ltd. | 08/24/2026SE |
| 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 |
| 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 |
More from Neoss Limited
| 510(k) | Device | Decision |
|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)DZL · Traditional | 09/29/2025SE |
| K201210 | The Micro Screw System, Micro Screw System BasicDZL · Traditional | 10/08/2021SE |
| K173819 | MyPlant II Implant SystemDZE · Traditional | 08/09/2018SE |
| K180360 | OKTAGON Implant SystemDZE · Traditional | 05/10/2018SE |
| K170287 | Dental Implants OKTAGON Bone Level Tapered DesignDZE · Traditional | 05/24/2017SE |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone LevelDZE · Traditional | 02/24/2017SE |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…NHA · Traditional | 11/21/2016SE |
| K143539 | Dental Implant OKTAGON Bone LevelDZE · Traditional | 08/31/2015SE |
| K132214 | Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…NHA · Traditional | 07/07/2014SE |
| K122807 | Dental Implant SystemDZE · Traditional | 06/13/2014SE |
Questions and answers
When was MP Pin flat without thread (36BMP000020/MP20) cleared by the FDA?
MP Pin flat without thread (36BMP000020/MP20) (K240321) received a 510(k) decision of Substantially Equivalent on October 17, 2024, 258 days after the submission was received.
What is the product code of K240321?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.