FDA Registration
Active
🇺🇸 United States
Pro-Dex Inc
Reg #: 3024788684
·
FEI: 3024788684
·
Expires 2026
Products
9
Proprietary Names
9
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- Pro-Dex Inc
- Registration Number
- 3024788684
- FEI Number
- 3024788684
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14401 Franklin Ave
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012105
Owner / Operator
- Firm Name
- PRO-DEX, INC.
- Operator Number
- 2081135
- Address
- 2361 McGaw Avenue, --
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-03-28 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2013-03-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2015-03-07 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2021-12-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-03-23 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2020-02-13 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2023-06-08 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 1992-10-23 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2020-07-23 |
Proprietary Names
Pro-Dex Surgical Driver (PDSD-5000-X)
PDCMF Driver (PDCMF-1000-X)
Atlas Pro Driver Hex Collet (APD-CA-001-1)
Atlas Pro Driver (APD-1000-1)
Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1)
Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBP-040-X)
Dynatip P/N 3293 Tip, Cover / Protector
Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X)
PDCMF Power Driver (PDCMF-1000-X)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility