Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DZL — Predicate Candidate Screening
80 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
300 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | 2025-09-29 | 255 | 0 |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025-08-13 | 83 | 0 |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025-06-27 | 270 | 0 |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | 2025-01-03 | 451 | 0 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | 2024-10-17 | 258 | 0 |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2024-09-17 | 301 | 0 |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | 2023-08-24 | 84 | 0 |
| K222367 | SAVE GBR | Dentis Co., Ltd. | 2023-03-23 | 230 | 0 |
| K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | 2021-10-08 | 521 | 0 |
| K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020-10-05 | 117 | 0 |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019-08-09 | 298 | 0 |
| K181854 | OssBuilder System | Osstem Implant Co., Ltd. | 2019-05-07 | 300 | 0 |
| K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | 2017-10-26 | 128 | 0 |
| K161857 | Salvin Tenting Screw System | Salvin Dental Specialties | 2017-04-28 | 296 | 0 |
| K160991 | Neo GBR System | Neobiotech Co., Ltd. | 2017-01-10 | 277 | 0 |
| K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | 2016-05-26 | 353 | 0 |
| K151195 | OsteoMed IMF Screw | Osteomed | 2015-09-21 | 140 | 0 |
| K140908 | JUGGERKNOT MINI SOFT ANCHOR | Biomet Sports Medicine | 2014-10-02 | 176 | 0 |
| K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SY | Hager& Meisinger GmbH | 2014-02-14 | 213 | 0 |
| K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISI | Hager& Meisinger GmbH | 2013-08-13 | 153 | 0 |
| K103084 | NEODENT GRAFT SCREW | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-14 | 118 | 0 |
| K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | Jeil Medical Corporation | 2011-02-08 | 215 | 0 |
| K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW | Salvin Dental Specialties, Inc. | 2010-05-10 | 109 | 0 |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | Osteogenics Biomedical, Inc. | 2010-03-01 | 89 | 0 |
| K093464 | RAPIDSORB PLUS SCREW SYSTEM | Synthes (Usa) | 2010-01-25 | 80 | 0 |
| K092855 | MILTEX MEMBRANE TACK KIT | Miltex, Inc. | 2009-12-29 | 104 | 0 |
| K083432 | DRILL FREE MMF SCREW | KLS Martin L.P. | 2009-03-31 | 131 | 0 |
| K080430 | STOMA BONE BLOCK SCREW | Storz AM Mark GmbH | 2008-11-21 | 276 | 0 |
| K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | Salvin Dental Specialties, Inc. | 2008-03-26 | 119 | 0 |
| K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM | Alpha-Bio Tec , Ltd. | 2007-03-30 | 100 | 0 |
| K051871 | STOMA BONE SCREW | Storz AM Mark GmbH | 2005-10-27 | 108 | 0 |
| K050606 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL | Synthes (Usa) | 2005-04-06 | 27 | 0 |
| K050515 | BONE BLOCK FIXATION SET | Straumann USA, Inc. | 2005-04-05 | 35 | 0 |
| K050535 | STRYKER MMF SCREW | Stryker Instruments | 2005-03-17 | 15 | 0 |
| K042573 | KLS MARTIN DRILL-FREE MMF SCREW | KLS-Martin L.P. | 2004-10-18 | 27 | 0 |
| K041887 | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS | Synthes (Usa) | 2004-08-19 | 38 | 0 |
| K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS | Synthes (Usa) | 2003-07-02 | 21 | 2 |
| K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | BioHorizons Implant Systems, Inc. | 2002-08-28 | 6 | 0 |
| K021850 | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS | Synthes (Usa) | 2002-06-10 | 5 | 0 |
| K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW | Walter Lorenz Surgical, Inc. | 2002-05-21 | 11 | 0 |
| K012486 | OSTEOMED BIORESORBABLE FIXATION SYSTEM | Osteomed Corp. | 2002-01-16 | 167 | 0 |
| K012908 | BIOPLATE RESORBABLE BONE SCREW | Bioplate, Inc. | 2001-11-28 | 90 | 0 |
| K011675 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | 2001-06-22 | 23 | 0 |
| K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | Synthes (Usa) | 2001-05-18 | 71 | 4 |
| K010527 | SYNTHES (USA) IMF SCREWS | Synthes (Usa) | 2001-04-25 | 62 | 0 |
| K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW | Synthes (Usa) | 2000-11-16 | 56 | 0 |
| K002423 | LACTOSORB PUSH SCREW | Biomet, Inc. | 2000-10-20 | 73 | 0 |
| K993493 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | 2000-01-07 | 84 | 1 |
| K993575 | RESOLVE QUICKANCHOR | Mitek Products | 1999-12-29 | 69 | 0 |
| K980760 | KLS-MARTIN MMF SCREW | KLS-Martin L.P. | 1999-12-21 | 662 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda