FDA Registration
Active
🇺🇸 United States
Power Dental USA, Inc.
Reg #: 3003969055
·
FEI: 3003969055
·
Expires 2026
Products
63
Proprietary Names
19
Establishment Types
5
Classifications
63
Registration Details
- Registration Name
- Power Dental USA, Inc.
- Registration Number
- 3003969055
- FEI Number
- 3003969055
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2809 Barney Ct
- City
- McHenry
- State
- IL
- ZIP
- 60051
- Country
- US
Owner / Operator
- Firm Name
- Power Dental USA
- Operator Number
- 10028819
- Address
- 2809 Barney Ct
- City
- McHenry
- State
- IL
- Postal Code
- 60051
- Country
- US
- Correspondent
- Jang H Lim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-05-14 |
| File, Periodontic | EMR | Class 1 | Dental | No | 2021-05-21 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2009-03-10 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2009-03-10 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-03-04 |
| Hoe, Periodontic | EMQ | Class 1 | Dental | No | 2021-05-21 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2009-03-10 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2011-12-15 |
| Knife, Margin Finishing, Operative | EJZ | Class 1 | Dental | No | 2009-03-10 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2011-12-15 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-02-20 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2021-05-21 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2011-11-02 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2011-11-02 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2011-11-02 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2009-03-10 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2011-11-02 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2021-11-19 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2011-11-16 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2011-12-16 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2013-03-04 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2021-05-21 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2011-12-15 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2021-06-02 |
| Mirror, General & Plastic Surgery | FTX | Class 1 | General, Plastic Surgery | No | 2011-11-02 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2011-11-02 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2011-11-02 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2021-05-21 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2009-03-10 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2018-06-26 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2011-11-02 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2011-11-02 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2021-06-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2021-05-21 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2011-12-15 |
| Handpiece (Brace), Drill | HBD | Class 1 | Neurology | No | 2016-05-02 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2021-06-02 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2011-11-02 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2009-03-10 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-05-21 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2009-03-10 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2011-11-02 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2013-03-04 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2021-05-21 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2009-03-10 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2011-12-16 |
| Curette, Operative | EKE | Class 1 | Dental | No | 2009-03-10 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-03-04 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2011-11-02 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2011-11-02 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2009-03-10 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2021-05-21 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2011-12-15 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2009-03-10 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2021-05-21 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2009-03-10 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2021-05-21 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2011-12-15 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2009-03-10 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2013-03-04 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2021-05-21 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2013-03-04 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2009-03-10 |
Proprietary Names
TRAY, SURGICAL, INSTRUMENT
FILE, PERIODONTIC
HOE, PERIODONTIC
OSTEOTOME
Headlamp
STARTER, BONE SCREW
FORCEPS, RONGEUR, SURGICAL
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
CARRIER, AMALGAM, OPERATIVE
Elevator
HEMOSTAT, SURGICAL
CLAMP, TOWEL
File, Bone, Surgical
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
SCALER, PERIODONTIC
CHISEL, BONE, SURGICAL
EVACUATOR, ORAL CAVITY
FORCEPS, RUBBER DAM CLAMP
CALIPER
Establishment Types
Remanufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device
Reprocess Single-Use Device
Manufacture Medical Device for Another Party (Contract Manufacturer)