FDA Device Registration & Listing · Jacksonville, FL, US · Registration 1057946
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2023-10-30 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2023-10-27 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2023-10-30 |
| MQN | External Mandibular Fixator And/Or Distractor | Dental | Class 2 | 872.4760 | 2023-10-27 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2023-10-27 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2023-10-27 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-10-30 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| KBG | Trocar, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2023-10-27 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2023-10-28 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Dental | Class 2 | 872.4120 | 2023-10-28 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-10-28 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2023-10-30 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | Class 2 | 882.5330 | 2023-10-28 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-28 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-27 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2023-10-27 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2024-11-19 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2023-10-27 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2023-10-30 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-10-27 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-27 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-20 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-10-30 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2023-10-27 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2023-10-27 |
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2023-10-28 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-11-15 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-10-27 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2023-10-30 |
| MQN | External Mandibular Fixator And/Or Distractor | Dental | Class 2 | 872.4760 | 2023-10-28 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2023-10-30 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-27 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-27 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2023-10-27 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2023-10-27 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2023-10-30 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-30 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HBW | Fastener, Plate, Cranioplasty | Neurology | Class 2 | 882.5360 | 2023-10-28 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Neurology | Class 2 | 882.5320 | 2023-10-28 |
| JXX | Forceps, Wire Closure, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-27 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| MOQ | Battery, Replacement, Rechargeable | General, Plastic Surgery | Class 1 | 878.4820 | 2023-10-30 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| MQN | External Mandibular Fixator And/Or Distractor | Dental | Class 2 | 872.4760 | 2023-10-27 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-27 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HRW | Dynamometer, Nonpowered | Orthopedic | Class 1 | 888.1250 | 2026-03-06 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-10-30 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2023-10-28 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-28 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| MQN | External Mandibular Fixator And/Or Distractor | Dental | Class 2 | 872.4760 | 2023-10-27 |
| JDQ | Cerclage, Fixation | Orthopedic | Class 2 | 888.3010 | 2023-10-28 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-27 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2023-10-30 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-28 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-30 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| PBJ | Cranial Distraction System | Neurology | Class 2 | 882.5330 | 2023-10-28 |
| MQN | External Mandibular Fixator And/Or Distractor | Dental | Class 2 | 872.4760 | 2023-10-27 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2023-10-27 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | Class 2 | 882.5330 | 2023-10-28 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-01-13 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-01-13 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2026-01-13 |
| HXE | Fork | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2023-10-30 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-27 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | Class 2 | 882.5330 | 2023-10-28 |
| JXS | Block, Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-30 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-10-30 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2023-10-27 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2023-10-27 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2023-10-27 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-10-27 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-27 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2023-10-27 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2023-10-27 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2023-10-28 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Dental | Class 2 | 872.4120 | 2023-10-28 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2023-10-30 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2023-10-28 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2023-10-30 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| PBJ | Cranial Distraction System | Neurology | Class 2 | 882.5330 | 2023-11-27 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-03 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-28 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2023-10-28 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2023-10-28 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Dental | Class 2 | 872.4120 | 2023-10-28 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-10-28 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-08-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-08-25 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2023-10-27 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9681383 | KLS Martin SE & Co. KG | Freiburg Baden-Wurttemberg, DE |
| 3014201171 | KLS Martin Malaysia Sdn. Bhd. | Simpang Ampat Pulau Pinang, MY |
| 9610905 | KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, DE |
| 3036795921 | KLS MARTIN SE & CO. KG | Fridingen Baden-Wurttemberg, DE |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K933337 | R & D Batteries, Inc. | R AND D BATTERY REPLACEMENT | 1994-04-05 |
| K873766 | Bowen & Company, Inc. | STERNAL POWER AWL | 1988-11-14 |
| K081806 | Idi Biomedical, LLC | IDI IMPLANT SYSTEM | 2008-11-07 |
| K120793 | Z-Systems AG | Z-LOOK3 EVO SLM | 2012-12-21 |
| K130140 | Intra-Lock International | INTRA-LOCK OP DENTAL IMPLANT | 2013-08-01 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Z-0010-2020 | Implant Direct Sybron Manufacturing, LLC | 2 | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. |
| Z-0017-2026 | S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil | 2 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;
IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;
IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N;
IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N;
IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N;
IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N;
IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N;
IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N;
IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N;
IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N;
IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N;
IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N;
IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N;
IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N;
IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N;
IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N;
IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N;
IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N;
IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N;
IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N;
IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N;
IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N;
IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N;
IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N;
IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515;
IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585;
IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813;
IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815;
IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085;
IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811;
IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N;
IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N;
IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N |
| Z-0018-2020 | Implant Direct Sybron Manufacturing, LLC | 2 | ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216.
The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. |
| Z-0019-2020 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 2 | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm
Catalog Number: 20-70024P |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007389672 | FRANKO SHEHZAD SURGICO PVT LTD. | Sialkot Punjab, PK |
| 3011499367 | HAZEL ENTERPRISES | Sialkot Punjab, PK |
| 3022748632 | TAURUS Medizintechnik GmbH | Fridingen an der Donau Baden-Wurttemberg, DE |
| 3012267976 | SURGIPROS LLC | Palmetto, FL, US |
| 8040179 | BASHIR JAMIL & BROTHERS (PVT.), LTD. | Sialkot Punjab, PK |
1057946 when referencing this establishment in official correspondence.