FDA Registration
Active
🇺🇸 United States
NORDENT MFG., INC.
Reg #: 1419489
·
FEI: 1419489
·
Expires 2026
Products
68
Proprietary Names
70
Establishment Types
4
Classifications
68
Registration Details
- Registration Name
- NORDENT MFG., INC.
- Registration Number
- 1419489
- FEI Number
- 1419489
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 610 BONNIE LANE
- City
- ELK GROVE VILLAGE
- State
- IL
- ZIP
- 60007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080025
Owner / Operator
- Firm Name
- NORDENT MFG., INC.
- Operator Number
- 1419489
- Address
- 610 BONNIE LANE, --
- City
- Elk Grove Village
- State
- IL
- Postal Code
- 60007
- Country
- US
- Correspondent
- Anant - Shah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2025-03-20 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2024-08-09 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 1978-02-03 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2024-02-12 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2025-03-20 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2018-09-05 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 1978-02-03 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 1978-02-02 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2025-03-20 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2018-09-05 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 1978-02-01 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2024-02-12 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2023-05-22 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2024-03-11 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2024-02-12 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2025-03-20 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2018-09-05 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2018-09-05 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2020-02-14 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2026-04-20 |
| File, Periodontic | EMR | Class 1 | Dental | No | 1978-02-03 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 1978-02-01 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2025-03-20 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2018-09-05 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-09-05 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2025-03-20 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2018-09-05 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2018-09-05 |
| Hoe, Periodontic | EMQ | Class 1 | Dental | No | 1978-02-03 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2024-02-12 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2018-09-05 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 1978-02-01 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2025-03-20 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2018-09-05 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2018-09-05 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2018-09-05 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2018-09-05 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 1978-02-01 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2024-02-05 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 1978-02-01 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2018-09-05 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2018-09-05 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 1978-02-01 |
| Laser, Dental, Soft Tissue | NVK | Class 2 | General, Plastic Surgery | No | 2025-03-20 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-03-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-03-20 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2018-09-05 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2018-09-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-09-05 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-08-09 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2018-09-05 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 1978-02-03 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 1978-02-01 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1978-02-01 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2025-03-20 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2018-09-05 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-09-05 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 1978-02-03 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2024-02-05 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2018-09-05 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 1978-02-03 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 1978-02-03 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1978-02-03 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2018-09-05 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2025-03-20 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 1978-02-01 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2018-09-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-09-05 |
Proprietary Names
I LED, I LED II, O-LIGHT, O-LIGHT II
Nordent Tape, Measuring, Rulers and Calipers
NORDENT ORAL SURGERY ELEVATORS
Surgical Mallet
ENDO 3
Nordent Spreaders
NORDENT PERIODONTAL PROBES
NORDENT PERIODONTAL FINISHING AND
OR SCALING CURETTES
AP-H, AP-H Plus
Nordent Lab Carvers
NORDENT AMALGAM BURNISHERS
Matrix Retainers
Brewer Rubber Dam Clamp Forcep
ultrasonic scaler
Mouth Gag
AI PEX
Nordent Needle Holder
Nordent Rongeur
Nordent
NORDENT PERIODONTAL FILES
NORDENT AMALGAM CONDENSERS
Implant Air
Nordent Surgical Extraction Forceps
Nordent Scalpel Handles
AI SURGERY
Nordent Surgical Scissors
Nordent Suction Tips
NORDENT OCHSENBEIN PERIO-CHISEL
Calipers
Nordent Band Pusher
NORDENT EXPLORERS
MOTOPEX
Nordent Dressing Pliers
Nordent Hemostat
Nordent Collar Scissors
Nordent Band Seater
NORDENT BONE FILES
Brewer Rubber Dam Clamp Forceps
NORDENT AMALGAM CARVERS
Nordent Endo Plugger
Nordent Amalgam Carrier
HATCHETS
NORDENT MARGIN TRIMMERS
HOES
CHISELS
D-Laser 16, D-Laser Blue, LX 16, LX16 Plus
Nordent Endo Excavator
Nordent Gingival Cord Packer
Nordent Dental Hand and Surgical Instruments Storage Cassette
Nordent Stainless Steel Graft Delivery Syringe with funnel
Nordent Crown Remover
NORDENT SCALERS
D600 LED
NORDENT EXCAVATORS
NORDENT PLASTIC FILLING INSTRUMENTS
MT-2
Nordent Cement Spatula
Nordent Tissue Forceps
NORDENT BONE CHISELS
Syringe, Cartridge
Nordent Articulating Paper Forceps
NORDENT BONE CURETTES
NORDENT PERIO-KNIVES
NORDENT PERIOSTEALS
Nordent Ligature Director
Ai Ray Lite
NORDENT MIRROR HANDLE
Nordent Mirrors
Nordent Periotomes
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility