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.
Cleared Devices (80)
| 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 |
| K103084 | NEODENT GRAFT SCREW | Jjgc Industria E Comercio DE Materiais Dentarios S | Feb 14, 2011 | SESE |
| K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | Jeil Medical Corporation | Feb 8, 2011 | SESE |
| K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW | Salvin Dental Specialties, Inc. | May 10, 2010 | SESE |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | Osteogenics Biomedical, Inc. | Mar 1, 2010 | SESE |
| K093464 | RAPIDSORB PLUS SCREW SYSTEM | Synthes (Usa) | Jan 25, 2010 | SESE |
| K092855 | MILTEX MEMBRANE TACK KIT | Miltex, Inc. | Dec 29, 2009 | SESE |
| K083432 | DRILL FREE MMF SCREW | KLS Martin L.P. | Mar 31, 2009 | SESE |
| K080430 | STOMA BONE BLOCK SCREW | Storz AM Mark GmbH | Nov 21, 2008 | SESE |
| K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | Salvin Dental Specialties, Inc. | Mar 26, 2008 | SESE |
| K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM | Alpha-Bio Tec , Ltd. | Mar 30, 2007 | SESE |
| K051871 | STOMA BONE SCREW | Storz AM Mark GmbH | Oct 27, 2005 | SESE |
| K050606 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) | Synthes (Usa) | Apr 6, 2005 | SESE |
| K050515 | BONE BLOCK FIXATION SET | Straumann USA, Inc. | Apr 5, 2005 | SESE |
| K050535 | STRYKER MMF SCREW | Stryker Instruments | Mar 17, 2005 | SESE |
| K042573 | KLS MARTIN DRILL-FREE MMF SCREW | KLS-Martin L.P. | Oct 18, 2004 | SESE |
| K041887 | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS | Synthes (Usa) | Aug 19, 2004 | SESE |
| K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS | Synthes (Usa) | Jul 2, 2003 | SESE |
| K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | BioHorizons Implant Systems, Inc. | Aug 28, 2002 | SESE |
| K021850 | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS | Synthes (Usa) | Jun 10, 2002 | SESE |
| K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW | Walter Lorenz Surgical, Inc. | May 21, 2002 | SESE |
| K012486 | OSTEOMED BIORESORBABLE FIXATION SYSTEM | Osteomed Corp. | Jan 16, 2002 | SESE |
| K012908 | BIOPLATE RESORBABLE BONE SCREW | Bioplate, Inc. | Nov 28, 2001 | SESE |
| K011675 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | Jun 22, 2001 | SESE |
| K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | Synthes (Usa) | May 18, 2001 | SESE |
| K010527 | SYNTHES (USA) IMF SCREWS | Synthes (Usa) | Apr 25, 2001 | SESE |
| K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW | Synthes (Usa) | Nov 16, 2000 | SESE |
| K002423 | LACTOSORB PUSH SCREW | Biomet, Inc. | Oct 20, 2000 | SESE |
| K993493 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | Jan 7, 2000 | SESE |
| K993575 | RESOLVE QUICKANCHOR | Mitek Products | Dec 29, 1999 | SESE |
| K980760 | KLS-MARTIN MMF SCREW | KLS-Martin L.P. | Dec 21, 1999 | SESE |
| K993327 | TALON ANCHOR SNAP-PAK | Mitek Products | Dec 16, 1999 | SESE |
| K992623 | MITEK MINI ANCHOR | Mitek Products | Nov 2, 1999 | SESE |
| K982951 | IMTEC BIOPIN | Imtec Corp. | Jun 21, 1999 | SESE |
| K983728 | LORENZ IMF SCREW | Walter Lorenz Surgical, Inc. | May 13, 1999 | SESE |
| K983485 | SYNTHES 1.3 MM SELF-DRILLING SCREW | Synthes (Usa) | Dec 21, 1998 | SESE |
| K981881 | DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING | Doctor'S Research Group, Inc. | Dec 2, 1998 | SESE |
| K981666 | 2.5 MM LACTOSORB SCREWS | Biomet, Inc. | Nov 3, 1998 | SESE |
| K982927 | QUICK TAP SELF DRILLING SCREW | Kinamed, Inc. | Sep 8, 1998 | SESE |
| K981459 | MEMBRANE TACK | Biomet, Inc. | Jul 14, 1998 | SESE |
| K981362 | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR | Synthes (Usa) | Jun 29, 1998 | SESE |
| K980199 | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS | Synthes (Usa) | Apr 17, 1998 | SESE |
| K974817 | DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM | Doctor'S Research Group, Inc. | Mar 13, 1998 | SESE |
| K974392 | LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM | Biovision GmbH | Jan 30, 1998 | SESE |
| K972480 | 3I BIORESORBABLE FIXATION TACK | Implant Innovations, Inc. | Dec 23, 1997 | SESE |
| K973180 | IMTEC BONE TAC | Imtec Corp. | Nov 18, 1997 | SESE |
| K973056 | BONE GRAFT SCREW SYSTEM | Bicon, Inc. | Nov 12, 1997 | SESE |
| K962774 | OSTEOMED QUICKFIX | Osteomed Corp. | Oct 10, 1997 | SESE |
| K963546 | SMF TITANIUM (TI) ALLOY BONE SCREWS | Synthes (Usa) | Jun 24, 1997 | SESE |
| K964261 | SMF STAINLESS STEEL BONE SCREWS | Synthes (Usa) | Apr 11, 1997 | SESE |
| K961418 | OSTEOMED MSS | Osteomed Corp. | Oct 25, 1996 | SESE |
| K960945 | IMZ MEMBRANE TACK SYSTEM | Interpore Intl. | May 24, 1996 | SESE |
| K955369 | MEMFIX | The Straumann Co. | Jan 23, 1996 | SESE |
| K955140 | 2.0 X 6MM SCREW | Brasseler USA I, L.P. | Jan 5, 1996 | SESE |
| K952167 | IMZ BONE TACK SYSTEM | Interpore Intl. | Nov 21, 1995 | SESE |
| K951510 | ACE BONE SCREW TACKING KIT | Ace Surgical Supply Co., Inc. | Aug 25, 1995 | SESE |
| K910427 | MEMFIX SCREWS | W. L. Gore & Associates, Inc. | Sep 30, 1991 | SESE |
| K911936 | OSTEOMED SBF SYSTEM (SBF) | Osteomed Corp. | Aug 21, 1991 | SESE |
| K911165 | SCREW, BONE, MAXILLOFACIAL | Tekno-Medical | Aug 20, 1991 | SESE |
| K770131 | LEW PROSTHETIC LOCKING DEVICE | Howmedica Corp. | Jan 28, 1977 | SESE |
| K761228 | LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM | Howmedica Corp. | Dec 15, 1976 | SESE |
Top Applicants
- Synthes (Usa) — 13 clearances
- Hager& Meisinger GmbH — 5 clearances
- Osteomed Corp. — 4 clearances
- Osstem Implant Co., Ltd. — 3 clearances
- Mitek Products — 3 clearances
