DZL — Screw, Fixation, Intraosseous Class II
FDA product code DZL covers "Screw, Fixation, Intraosseous", a Class II medical device regulated under 21 CFR 872.4880. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DZL
- Device Class
- Class II
- Regulation Number
- 872.4880
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254286 | Dentalmaster(Xiamen)Medical Technology Co | Guided Bone Regeneration System | Aug 24, 2026 |
| K250123 | Hager And Meisinger | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Sep 29, 2025 |
| K251569 | Osstem Implant Co | Bone Screw | Aug 13, 2025 |
| K243190 | Ustomed Instrumente Ulrich Storz Gmbh And Co. Kg | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Jun 27, 2025 |
| K233419 | Proimtech Saglik Urunleri Anonim Sirketi | GBR System | Jan 3, 2025 |
| K240321 | Hager And Meisinger | MP Pin flat without thread (36BMP000020/MP20) | Oct 17, 2024 |
| K233721 | Kls-Martin L.P | KLS Martin Drill-Free MMF Screw | Sep 17, 2024 |
| K231599 | Stryker Leibinger Gmbh And Co Kg | Stryker MP, Mandible, HMMF and MMF AXS Screws | Aug 24, 2023 |
| K222367 | Dentis Co | SAVE GBR | Mar 23, 2023 |
| K201210 | Hager And Meisinger | The Micro Screw System, Micro Screw System Basic | Oct 8, 2021 |
| K201561 | Neoss Limited | Membrane Screws and Membrane Tacks | Oct 5, 2020 |
| K182881 | Osstem Implant Co | Bone Screw, Bone Tack | Aug 9, 2019 |
| K181854 | Osstem Implant Co | OssBuilder System | May 7, 2019 |
| K171831 | Intra-Lock International | Intra-Lock Bone Fixation System | Oct 26, 2017 |
| K161857 | Salvin Dental Specialties | Salvin Tenting Screw System | Apr 28, 2017 |
| K160991 | Neobiotech Co | Neo GBR System | Jan 10, 2017 |
| K151540 | Eli-Ka Technologies | MC BIO Supertack Tack 3mm, 4mm and 5mm | May 26, 2016 |
| K151195 | Osteomed | OsteoMed IMF Screw | Sep 21, 2015 |
| K140908 | Biomet Sports Medicine | JUGGERKNOT MINI SOFT ANCHOR | Oct 2, 2014 |
| K132212 | Hager And Meisinger | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTE | Feb 14, 2014 |