FDA Device Registration & Listing · CHARLOTTE, NC, US · Registration 1066741
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2001-06-06 |
| EMP | Marker, Periodontic | Dental | Class 1 | 872.4565 | 2023-06-16 |
| NUN | Bone Grafting Material, Human Source | Dental | Class 2 | 872.3930 | 2024-05-28 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2013-02-01 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2001-06-06 |
| LYC | Bone Grafting Material, Synthetic | Dental | Class 2 | 872.3930 | 2012-08-28 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2001-06-06 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2025-09-22 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-09-22 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2020-10-20 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2025-08-07 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2011-12-27 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2011-12-27 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2025-09-18 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2001-06-06 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2001-06-06 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2013-02-01 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2001-06-06 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2014-10-20 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-16 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2001-06-06 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-06-16 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | General, Plastic Surgery | Class 2 | 878.5035 | 2025-09-18 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-06-06 |
| NPL | Barrier, Animal Source, Intraoral | Dental | Class 2 | 872.3930 | 2024-05-28 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-06-06 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2023-06-16 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2023-06-16 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2001-06-06 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2023-06-16 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-09-18 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2008-06-17 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2025-09-18 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2023-06-16 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-09-18 |
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2001-06-06 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2025-09-18 |
| NPL | Barrier, Animal Source, Intraoral | Dental | Class 2 | 872.3930 | 2026-03-02 |
| NPM | Bone Grafting Material, Animal Source | Dental | Class 2 | 872.3930 | 2024-05-16 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2001-06-06 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2001-06-06 |
| NPL | Barrier, Animal Source, Intraoral | Dental | Class 2 | 872.3930 | 2012-06-06 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unknown | Class U | N/A | 2024-05-28 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2001-06-06 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2025-11-19 |
| NPL | Barrier, Animal Source, Intraoral | Dental | Class 2 | 872.3930 | 2016-10-26 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2025-09-22 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2001-06-06 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2001-06-06 |
| NUN | Bone Grafting Material, Human Source | Dental | Class 2 | 872.3930 | 2017-02-18 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-09-18 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2023-06-16 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2001-06-06 |
| NPK | Barrier, Synthetic, Intraoral | Dental | Class 2 | 872.3930 | 2021-12-15 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2001-06-06 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-02-01 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| NRU | Chair, Dental, Without Operative Unit | Dental | Class 1 | 872.6250 | 2025-09-22 |
| NPM | Bone Grafting Material, Animal Source | Dental | Class 2 | 872.3930 | 2024-05-28 |
| LYC | Bone Grafting Material, Synthetic | Dental | Class 2 | 872.3930 | 2024-05-28 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2001-06-06 |
| NPL | Barrier, Animal Source, Intraoral | Dental | Class 2 | 872.3930 | 2024-05-28 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2134751 | YOUNG MICROBRUSH LLC | GRAFTON, WI, US |
| 3027615 | AMERICAN EAGLE INSTRUMENTS | Missoula, MT, US |
| 8022249 | GERMIPHENE CORP. | BRANTFORD Ontario, CA |
| 1941138 | YOUNG DENTAL MANUFACTURING CO 1, LLC. | EARTH CITY, MO, US |
| 2024980 | YOUNG INNOVATIONS INC. | Algonquin, IL, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K052493 | Steiner Laboratories | SOCKET GRAFT | 2006-06-09 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| K914369 | Deroyal Industries, Inc. | QUALTEX MAGNETIC INSTRUMENT DRAPE | 1991-12-02 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016544015 | ARCULANT, INC. | Santa Clara, CA, US |
| 1055890 | PRINCETON MEDICAL GROUP, INC. | Franklin, TN, US |
| 3004371426 | Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, DE |
| 3010287737 | BAECHLER FEINTECH AG | Hoelstein Basel-Landschaft, CH |
| 3003675041 | SURGICAL INSTRUMENTS BELGIUM SA | GEMBLOUX Namur, BE |
1066741 when referencing this establishment in official correspondence.