Screw, Fixation, Intraosseous
Regulation 872.4880
1510(k)s in 12 months (81 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in DZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (Usa) | 13 | 0 |
| Hager& Meisinger GmbH | 5 | 0 |
| Osteomed | 5 | 0 |
| KLS Martin L.P. | 4 | 0 |
| Synthes USA HQ, Inc. | 0 | 4 |
| BioHorizons Implant Systems, Inc. | 3 | 0 |
| Biomet, Inc. | 3 | 0 |
| Mitek Products | 3 | 0 |
| Osstem Implant Co., Ltd. | 3 | 0 |
| Salvin Dental Specialties | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2026 | K254286 | Guided Bone Regeneration System DentalMaster(Xiamen)Medical Technology Co., Ltd., CN | DZL |
| Sep 29, 2025 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) Hager& Meisinger GmbH, DE | DZL |
| Aug 13, 2025 | K251569 | Bone Screw Osstem Implant Co., Ltd., KR | DZL |
| Jun 27, 2025 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN Ustomed Instrumente Ulrich Storz GmbH & Co. KG, DE | DZL |
| Jan 3, 2025 | K233419 | GBR System Proimtech Saglik Urunleri Anonim Sirketi, TR | DZL |
| Oct 17, 2024 | K240321 | MP Pin flat without thread (36BMP000020/MP20) Hager& Meisinger GmbH, DE | DZL |
| Sep 17, 2024 | K233721 | KLS Martin Drill-Free MMF Screw KLS-Martin L.P. | DZL |
| Aug 24, 2023 | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws Stryker Leibinger GmbH & Co KG, DE | DZL |
| Mar 23, 2023 | K222367 | SAVE GBR Dentis Co., Ltd., KR | DZL |
| Oct 8, 2021 | K201210 | The Micro Screw System, Micro Screw System Basic Hager& Meisinger GmbH, DE | DZL |
| Oct 5, 2020 | K201561 | Membrane Screws and Membrane Tacks Neoss Limited, GB | DZL |
| Aug 9, 2019 | K182881 | Bone Screw, Bone Tack Osstem Implant Co., Ltd., KR | DZL |
| May 7, 2019 | K181854 | OssBuilder System Osstem Implant Co., Ltd., KR | DZL |
| Oct 26, 2017 | K171831 | Intra-Lock Bone Fixation System Intra-Lock International, Inc. | DZL |
| Apr 28, 2017 | K161857 | Salvin Tenting Screw System Salvin Dental Specialties | DZL |
| Jan 10, 2017 | K160991 | Neo GBR System Neobiotech Co., Ltd., KR | DZL |
| May 26, 2016 | K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm Eli-Ka Technologies | DZL |
| Sep 21, 2015 | K151195 | OsteoMed IMF Screw Osteomed | DZL |
| Oct 2, 2014 | K140908 | JUGGERKNOT MINI SOFT ANCHOR Biomet Sports Medicine | DZL |
| Feb 14, 2014 | K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL Hager& Meisinger GmbH, DE | DZL |
| Aug 13, 2013 | K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT Hager& Meisinger GmbH, DE | DZL |
| Feb 14, 2011 | K103084 | NEODENT GRAFT SCREW Jjgc Industria E Comercio DE Materiais Dentarios S | DZL |
| Feb 8, 2011 | K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 Jeil Medical Corporation | DZL |
| May 10, 2010 | K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW Salvin Dental Specialties, Inc. | DZL |
| Mar 1, 2010 | K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# Osteogenics Biomedical, Inc. | DZL |
| Jan 25, 2010 | K093464 | RAPIDSORB PLUS SCREW SYSTEM Synthes (Usa) | DZL |
| Dec 29, 2009 | K092855 | MILTEX MEMBRANE TACK KIT Miltex, Inc. | DZL |
| Mar 31, 2009 | K083432 | DRILL FREE MMF SCREW KLS Martin L.P. | DZL |
| Nov 21, 2008 | K080430 | STOMA BONE BLOCK SCREW Storz AM Mark GmbH, DE | DZL |
| Mar 26, 2008 | K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW Salvin Dental Specialties, Inc. | DZL |
| Mar 30, 2007 | K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM Alpha-Bio Tec , Ltd. | DZL |
| Oct 27, 2005 | K051871 | STOMA BONE SCREW Storz AM Mark GmbH, DE | DZL |
| Apr 6, 2005 | K050606 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) Synthes (Usa) | DZL |
| Apr 5, 2005 | K050515 | BONE BLOCK FIXATION SET Straumann USA, Inc. | DZL |
| Mar 17, 2005 | K050535 | STRYKER MMF SCREW Stryker Instruments | DZL |
| Oct 18, 2004 | K042573 | KLS MARTIN DRILL-FREE MMF SCREW KLS-Martin L.P. | DZL |
| Aug 19, 2004 | K041887 | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS Synthes (Usa) | DZL |
| Jul 2, 2003 | K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS Synthes (Usa) | DZL |
| Aug 28, 2002 | K022790 | THE AUTOTAC SYSTEM TITANIUM TACK BioHorizons Implant Systems, Inc. | DZL |
| Jun 10, 2002 | K021850 | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS Synthes (Usa) | DZL |
| May 21, 2002 | K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW Walter Lorenz Surgical, Inc. | DZL |
| Jan 16, 2002 | K012486 | OSTEOMED BIORESORBABLE FIXATION SYSTEM Osteomed Corp. | DZL |
| Nov 28, 2001 | K012908 | BIOPLATE RESORBABLE BONE SCREW Bioplate, Inc. | DZL |
| Jun 22, 2001 | K011675 | THE AUTOTAC SYSTEM BioHorizons Implant Systems, Inc. | DZL |
| May 18, 2001 | K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR Synthes (Usa) | DZL |
| Apr 25, 2001 | K010527 | SYNTHES (USA) IMF SCREWS Synthes (Usa) | DZL |
| Nov 16, 2000 | K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW Synthes (Usa) | DZL |
| Oct 20, 2000 | K002423 | LACTOSORB PUSH SCREW Biomet, Inc. | DZL |
| Jan 7, 2000 | K993493 | THE AUTOTAC SYSTEM BioHorizons Implant Systems, Inc. | DZL |
| Dec 29, 1999 | K993575 | RESOLVE QUICKANCHOR Mitek Products | DZL |
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