Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4880](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4880) → DZL — Screw, Fixation, Intraosseous # DZL · Screw, Fixation, Intraosseous _Dental · 21 CFR 872.4880 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL ## Overview - **Product Code:** DZL - **Device Name:** Screw, Fixation, Intraosseous - **Regulation:** [21 CFR 872.4880](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4880) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K250123.md) | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | Sep 29, 2025 | SESE | | [K251569](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K251569.md) | Bone Screw | Osstem Implant Co., Ltd. | Aug 13, 2025 | SESE | | [K243190](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K243190.md) | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | Jun 27, 2025 | SESE | | [K233419](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K233419.md) | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | Jan 3, 2025 | SESE | | [K240321](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K240321.md) | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | Oct 17, 2024 | SESE | | [K233721](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K233721.md) | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | Sep 17, 2024 | SESE | | [K231599](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K231599.md) | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | Aug 24, 2023 | SESE | | [K222367](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K222367.md) | SAVE GBR | Dentis Co., Ltd. | Mar 23, 2023 | SESE | | [K201210](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K201210.md) | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | Oct 8, 2021 | SESE | | [K201561](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K201561.md) | Membrane Screws and Membrane Tacks | Neoss Limited | Oct 5, 2020 | SESE | | [K182881](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K182881.md) | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | Aug 9, 2019 | SESE | | [K181854](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K181854.md) | OssBuilder System | Osstem Implant Co., Ltd. | May 7, 2019 | SESE | | [K171831](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K171831.md) | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | Oct 26, 2017 | SESE | | [K161857](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K161857.md) | Salvin Tenting Screw System | Salvin Dental Specialties | Apr 28, 2017 | SESE | | [K160991](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K160991.md) | Neo GBR System | Neobiotech Co., Ltd. | Jan 10, 2017 | SESE | | [K151540](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K151540.md) | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | May 26, 2016 | SESE | | [K151195](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K151195.md) | OsteoMed IMF Screw | Osteomed | Sep 21, 2015 | SESE | | [K140908](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K140908.md) | JUGGERKNOT MINI SOFT ANCHOR | Biomet Sports Medicine | Oct 2, 2014 | SESE | | [K132212](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K132212.md) | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | Hager& Meisinger GmbH | Feb 14, 2014 | SESE | | [K130682](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K130682.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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