DZL · Screw, Fixation, Intraosseous
Dental · 21 CFR 872.4880 · Class 2
Overview
| Product Code | DZL |
|---|---|
| Device Name | Screw, Fixation, Intraosseous |
| Regulation | 21 CFR 872.4880 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 80)
Showing 20 most recent of 80 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | Sep 29, 2025 | SESE |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | Aug 13, 2025 | SESE |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | Jun 27, 2025 | SESE |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | Jan 3, 2025 | SESE |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | Oct 17, 2024 | SESE |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | Sep 17, 2024 | SESE |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | Aug 24, 2023 | SESE |
| K222367 | SAVE GBR | Dentis Co., Ltd. | Mar 23, 2023 | SESE |
| K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | Oct 8, 2021 | SESE |
| K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | Oct 5, 2020 | SESE |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | Aug 9, 2019 | SESE |
| K181854 | OssBuilder System | Osstem Implant Co., Ltd. | May 7, 2019 | SESE |
| K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | Oct 26, 2017 | SESE |
| K161857 | Salvin Tenting Screw System | Salvin Dental Specialties | Apr 28, 2017 | SESE |
| K160991 | Neo GBR System | Neobiotech Co., Ltd. | Jan 10, 2017 | SESE |
| K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | May 26, 2016 | SESE |
| K151195 | OsteoMed IMF Screw | Osteomed | Sep 21, 2015 | SESE |
| K140908 | JUGGERKNOT MINI SOFT ANCHOR | Biomet Sports Medicine | Oct 2, 2014 | SESE |
| K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | Hager& Meisinger GmbH | Feb 14, 2014 | SESE |
| K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | Hager& Meisinger GmbH | Aug 13, 2013 | SESE |
Top Applicants
- Synthes (Usa) — 13 clearances
- Hager& Meisinger GmbH — 5 clearances
- Osteomed Corp. — 4 clearances
- BioHorizons Implant Systems, Inc. — 3 clearances
- Biomet, Inc. — 3 clearances
