FDA Product Code
FDA Product Code JEY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4760
510(k) Clearances — 294 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993862 | MODUS SAGITTAL SPLIT PLATE | The Straumann Co. | 1999-12-29 | Traditional | PDF ↗ |
| K992683 | MODUS 2.5 MANDIBULAR TRAUMA SET | Medartis AG | 1999-11-24 | Traditional | PDF ↗ |
| K992682 | MODUS 2.5 MANDIBULAR RECONSTRUCTION SET | Medartis AG | 1999-11-24 | Traditional | PDF ↗ |
| K992330 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Biomedics | 1999-11-23 | Traditional | PDF ↗ |
| K992158 | LACTOSORB SHEETS | Biomet, Inc. | 1999-08-20 | Traditional | PDF ↗ |
| K990920 | DRG TITANIUM BONE PLATE | Doctor'S Research Group, Inc. | 1999-06-10 | Traditional | PDF ↗ |
| K990140 | NORMED BONE TRANSPORT | Ace Surgical Supply Co., Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K983360 | MACROPORE PROTECTIVE SHEET | Pacific Materials and Interfaces | 1999-03-19 | Traditional | PDF ↗ |
| K982721 | BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM | Bionx Implants, Inc. | 1999-02-17 | Traditional | PDF ↗ |
| K984230 | OSTEO-MESH TM-300 | Osteogenics Biomedical, Inc. | 1999-02-04 | Traditional | PDF ↗ |
| K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | Howmedica, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K983535 | THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 | Hans Hermann GmbH | 1998-12-29 | Traditional | PDF ↗ |
| K983528 | MICRO DYNAMIC MESH | Howmedica Corp. | 1998-12-23 | Traditional | PDF ↗ |
| K981526 | ACE ALVEOLAR DISTRACTOR | Ace Surgical Supply Co., Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K982139 | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM | Bionx Implants, Inc. | 1998-09-15 | Traditional | PDF ↗ |
| K981890 | SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES | Synthes (Usa) | 1998-08-18 | Traditional | PDF ↗ |
| K980983 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Biomedics | 1998-06-09 | Traditional | PDF ↗ |
| K980927 | LACTOSORB PANELS AND FASTENERS | Biomet, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K981070 | 20-HOLE ADAPTATION PLATE | Biomet, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | Walter Lorenz Surgical, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K973924 | FRIOS BONESHIELD | Friatec AG | 1998-05-07 | Traditional | PDF ↗ |
| K974555 | SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) | Synthes (Usa) | 1998-03-03 | Traditional | PDF ↗ |
| K974554 | SYNTHES RESORBABLE FIXATION SYSTEM | Synthes (Usa) | 1998-02-24 | Traditional | PDF ↗ |
| K973484 | CHIN DISTRACTOR | Howmedica, Inc. | 1997-12-02 | Traditional | PDF ↗ |
| K973145 | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM | Sofamor Danek USA,Inc. | 1997-11-19 | Traditional | PDF ↗ |
| K972463 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Biomedics | 1997-09-25 | Traditional | PDF ↗ |
| K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | Walter Lorenz Surgical, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K972166 | GUERRERO - BELL DISTRACTOR | Howmedica Leibinger, Inc. | 1997-08-11 | Traditional | PDF ↗ |
| K972154 | COHEN DISTRACTOR | Howmedica Leibinger, Inc. | 1997-08-11 | Traditional | PDF ↗ |
| K971987 | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR | Synthes (Usa) | 1997-06-24 | Traditional | PDF ↗ |
| K970841 | IMTEC/TITANIUM MESH | Imtec Corp. | 1997-04-30 | Traditional | PDF ↗ |
| K970911 | LEE PLATE | Howmedica Leibinger, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K970256 | INTRAORAL MANDIBULAR DISTRACTION DEVICE | Medicon EG | 1997-03-11 | Traditional | PDF ↗ |
| K964649 | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE | Howmedica Leibinger, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K964328 | SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE | Synthes (Usa) | 1996-12-13 | Traditional | PDF ↗ |
| K963394 | OSTEOMED TRAM | Osteomed Corp. | 1996-11-14 | Traditional | PDF ↗ |
| K963740 | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS | Howmedica Leibinger, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K961976 | THE BIOPLATE FIXATION SYSTEM | Biomedics | 1996-08-16 | Traditional | PDF ↗ |
| K961421 | SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM | Synthes (Usa) | 1996-06-26 | Traditional | PDF ↗ |
| K960514 | TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) | Anspach Fixation Systems | 1996-04-15 | Traditional | PDF ↗ |
| K960914 | 3I OSSEOUS FIXATION SYSTEM(S) | Implant Innovations, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K953806 | SYNTHES (USA) MIDFACIAL SYSTEM | Synthes (Usa) | 1996-03-08 | Traditional | PDF ↗ |
| K954385 | SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM | Synthes (Usa) | 1996-03-08 | Traditional | PDF ↗ |
| K953273 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM | Biomedics | 1995-09-29 | Traditional | PDF ↗ |
| K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM | Walter Lorenz Surgical, Inc. | 1995-09-28 | Traditional | PDF ↗ |
| K945500 | WELLS JOHNSON FIXATION SYSTEM | Wells Johnson Co. | 1995-09-21 | Traditional | PDF ↗ |
| K953386 | 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS | Implant Innovations, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K952812 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS | Implant Innovations, Inc. | 1995-08-30 | Traditional | PDF ↗ |
| K952811 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS | Implant Innovations, Inc. | 1995-08-30 | Traditional | PDF ↗ |
| K951689 | TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM | Medicon EG | 1995-07-27 | Traditional | PDF ↗ |
| K951687 | MESH TITANIUM IMPLANT SYSTEM | Medicon EG | 1995-07-27 | Traditional | PDF ↗ |
| K951690 | TITANIUM MINIPLATE SYSTEM | Medicon EG | 1995-07-26 | Traditional | PDF ↗ |
| K951691 | CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM | Medicon EG | 1995-07-26 | Traditional | PDF ↗ |
| K951688 | MICRO TITANIUM PLATE SYSTEM | Medicon EG | 1995-07-26 | Traditional | PDF ↗ |
| K950595 | LUHR MANDIBULAR/SMALL FIXATION IMPLANTS | Howmedica Corp. | 1995-07-12 | Traditional | PDF ↗ |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | Medicon, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K951392 | MINIBONEPLATE SYSTEM | Ace Surgical Supply Co., Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K950045 | KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM | Karl Leibinger GmbH U. Co. KG | 1995-03-23 | Traditional | PDF ↗ |
| K943071 | THE TITANIUM FIXATION SYSTEM | Biomedics | 1995-01-06 | Traditional | PDF ↗ |
| K944565 | KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) | KLS-Martin L.P. | 1994-10-18 | Traditional | PDF ↗ |
| K944560 | MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST | KLS-Martin L.P. | 1994-10-18 | Traditional | PDF ↗ |
| K944561 | MICRO OSTEOSYNTHESIS SYSTEM (1.0) | KLS-Martin L.P. | 1994-10-18 | Traditional | PDF ↗ |
| K943348 | KLS CHIN PLATE SYSTEM | Patton, Boggs & Blow | 1994-10-04 | Traditional | PDF ↗ |
| K943346 | MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM | Patton, Boggs & Blow | 1994-10-04 | Traditional | PDF ↗ |
| K943345 | MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM | Patton, Boggs & Blow | 1994-10-04 | Traditional | PDF ↗ |
| K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM | Patton, Boggs & Blow | 1994-10-04 | Traditional | PDF ↗ |
| K931539 | NORMED TITANIUM MINIPLATE SYSTEM | Normed Medizin-Technik GmbH | 1994-07-05 | Traditional | PDF ↗ |
| K923705 | AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS | Aesculap, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K932492 | IMPLANTOLOGY MODULE, MODEL 2175 | Micro Surgical Instruments Corp. | 1993-10-05 | Traditional | PDF ↗ |
| K923419 | TISMESH SYSTEM | Ti-Mesh, Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K924138 | OSTEOMED M3 SYSTEM (SBF SYSTEM) | Osteomed Corp. | 1993-02-17 | Traditional | PDF ↗ |
| K922741 | LORENZ 1.0 MM SYSTEM | Walter Lorenz Surgical, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K923802 | TIMESH TITANIUM MINI-SOFTPLATE/SCREW | Ti-Mesh, Inc. | 1992-10-26 | Traditional | PDF ↗ |
| K921801 | MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM | Techmedica, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K913688 | BUD MAXILLOFACIAL IMPLANT SYSTEM | Bud Industries, Inc. | 1992-05-05 | Traditional | PDF ↗ |
| K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM | Walter Lorenz Surgical, Inc. | 1991-02-20 | Traditional | PDF ↗ |
| K901940 | LUHR MICRO MESH | Howmedica Corp. | 1990-09-06 | Traditional | PDF ↗ |
| K901941 | LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES | Howmedica Corp. | 1990-09-06 | Traditional | PDF ↗ |
| K901094 | HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY | Grimm & Norton | 1990-04-27 | Traditional | PDF ↗ |
| K901095 | BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY | Grimm & Norton | 1990-04-27 | Traditional | PDF ↗ |
| K896404 | TITAMED ANTWERP SYSTEM | Optik | 1990-04-16 | Traditional | PDF ↗ |
| K884523 | MARTIN-CHAMPY TITAN SET | Buschmann Surgical Products | 1988-12-08 | Traditional | PDF ↗ |
| K873926 | STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT | Storz Instrument Co. | 1988-02-19 | Traditional | PDF ↗ |
| K870041 | FLEXIBLE FASCICULATED BONE PLATE | The Deca Co. | 1987-07-17 | Traditional | PDF ↗ |
| K862532 | DUMBACH TITANIUM MESH IMPLANT SYSTEM | Walter Lorenz Surgical, Inc. | 1986-09-05 | Traditional | PDF ↗ |
| K862505 | MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM | Walter Lorenz Surgical, Inc. | 1986-08-07 | Traditional | PDF ↗ |
| K862534 | PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS | Walter Lorenz Surgical, Inc. | 1986-08-07 | Traditional | PDF ↗ |
| K862533 | MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE | Walter Lorenz Surgical, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K862482 | STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS | Walter Lorenz Surgical, Inc. | 1986-07-25 | Traditional | PDF ↗ |
| K862139 | IMTECH FIXATION SYSTEMS | Imtech, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K855224 | ACROMED NESTED BONE PLATE | Buckman Co., Inc. | 1986-02-04 | Traditional | PDF ↗ |
| K855030 | CHAMPY BONE PLATES & BONE SCREWS | Advanced Biosearch Assn. | 1986-01-30 | Traditional | PDF ↗ |
| K854886 | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS | Walter Lorenz Surgical, Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K840955 | CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD | Synthes (Usa) | 1984-06-19 | Traditional | PDF ↗ |
Product code JEY · Class II · Dental. Data: openFDA.