Data / Medical devices / United States / Nordent MFG., Inc.
Nordent MFG., Inc.: FDA-registered device maker in Elk Grove Village, IL, United States, 11 510(k) clearances
Nordent MFG., Inc. is registered with the FDA (registration 1419489) in Elk Grove Village, IL, United States. It lists 68 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1419489
- Address
- 610 Bonnie Lane, Elk Grove Village, IL, United States, 60007
- Owner or operator
- NORDENT MFG., INC. (1419489)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 1, 1978
- Registered through
- 2026
- Brand names listed
- AI PEX, AI SURGERY, AP-H, AP-H Plus, Ai Ray Lite, Brewer Rubber Dam Clamp Forcep, Brewer Rubber Dam Clamp Forceps, CHISELS, Calipers and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Burnisher, Operative | EKJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carver, Dental Amalgam, Operative | EKH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Carver, Wax, Dental | EIK | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Condenser, Amalgam And Foil, Operative | EKG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Curette, Periodontic | EMS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| File, Periodontic | EMR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hoe, Periodontic | EMQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Hand, Calculus Removal | ELA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Knife, Periodontic | EMO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retainer, Matrix | JEP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Collar And Crown | EIR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| November 23, 2022 | K222569 | Ai Ray Dental X-Ray Device | EHD | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 21, 2022 | K211358 | Implanter incl. Accessories | EBW | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| September 28, 2022 | K221548 | Dental Air Polishing Handpiece | EFB | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 10, 2022 | K210367 | D-Laser Blue, D-Laser 16 | NVK | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 2, 2022 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | ELC | Substantially Equivalent | Ttbio Corp. | accessdata.fda.gov |
| January 13, 2022 | K203706 | Dental Electric Motor | EBW | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 10, 2021 | K203320 | Endo Motor | EKX | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| December 18, 2018 | K181087 | Apex Locator, DPEX III | LQY | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 18, 2011 | K111290 | PIEZO BONE SURGERY | DZI | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 19, 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | EBZ | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 21, 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | ELC | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Plugger, Root Canal, Endodontic
- All makers of Carver, Dental Amalgam, Operative
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Burnisher, Operative
- All makers of Carrier, Amalgam, Operative
- All makers of Chisel, Bone, Surgical
Updated November 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.