Product code DZL
Current FDA Classification
- Device name
- Screw, Fixation, Intraosseous
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4880
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | 2025-09-29 |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025-08-13 |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025-06-27 |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | 2025-01-03 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | 2024-10-17 |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2024-09-17 |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | 2023-08-24 |
| K222367 | SAVE GBR | Dentis Co., Ltd. | 2023-03-23 |
| K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | 2021-10-08 |
| K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020-10-05 |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019-08-09 |
| K181854 | OssBuilder System | Osstem Implant Co., Ltd. | 2019-05-07 |
| K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | 2017-10-26 |
| K161857 | Salvin Tenting Screw System | Salvin Dental Specialties | 2017-04-28 |
| K160991 | Neo GBR System | Neobiotech Co., Ltd. | 2017-01-10 |
| K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | 2016-05-26 |
| K151195 | OsteoMed IMF Screw | Osteomed | 2015-09-21 |
| K140908 | JUGGERKNOT MINI SOFT ANCHOR | Biomet Sports Medicine | 2014-10-02 |
| K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | Hager& Meisinger GmbH | 2014-02-14 |
| K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | Hager& Meisinger GmbH | 2013-08-13 |
| K103084 | NEODENT GRAFT SCREW | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-14 |
| K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | Jeil Medical Corporation | 2011-02-08 |
| K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW | Salvin Dental Specialties, Inc. | 2010-05-10 |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | Osteogenics Biomedical, Inc. | 2010-03-01 |
| K093464 | RAPIDSORB PLUS SCREW SYSTEM | Synthes (Usa) | 2010-01-25 |
| K092855 | MILTEX MEMBRANE TACK KIT | Miltex, Inc. | 2009-12-29 |
| K083432 | DRILL FREE MMF SCREW | KLS Martin L.P. | 2009-03-31 |
| K080430 | STOMA BONE BLOCK SCREW | Storz AM Mark GmbH | 2008-11-21 |
| K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | Salvin Dental Specialties, Inc. | 2008-03-26 |
| K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM | Alpha-Bio Tec , Ltd. | 2007-03-30 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800000987309 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040655909 | OssBuilder System | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040655886 | OssBuilder System | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040655862 | OssBuilder System | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040655848 | OssBuilder System | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040654599 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040644132 | Bone Screw | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040644118 | Bone Screw | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987361 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987354 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987347 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987330 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987323 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987316 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800000987293 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2026-03-09 |
| 08800040644095 | Bone Screw | Osstem Implant Co., Ltd. | 2026-03-09 |
| ESAM23053120 | STOMA® | Storz am Mark GmbH | 2025-04-30 |
| D765PFTK100 | Pro-fix™ Precision Fixation System | Osteogenics Biomedical Inc | 2025-03-31 |
| 00888118142894 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2025-01-23 |
| 00888118142900 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2025-01-23 |
| 00888118145222 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2024-12-23 |
| 00888118145239 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2024-12-23 |
| 00888118145246 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2024-12-23 |
| 00888118145253 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2024-12-23 |
| 00888118145260 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2024-12-23 |
| 00888118145277 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2024-12-23 |
| 08056992093010 | MCBio Supertack Tack 3mm - N.5 | MC BIO SRL | 2024-12-17 |
| 08056992093027 | MCBio Supertack Tack 3mm - N.10 | MC BIO SRL | 2024-12-17 |
| 00817421021442 | X-Guide | XNAV TECHNOLOGIES LLC | 2021-01-25 |
| 00817421021343 | X-Guide | XNAV TECHNOLOGIES LLC | 2021-01-25 |