Data / Medical devices / United States / Rex Implants, Inc
Rex Implants, Inc: FDA-registered device maker in Columbus, OH, United States, 1 510(k) clearance
Rex Implants, Inc is registered with the FDA (registration 3014174860) in Columbus, OH, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014174860
- Address
- 850 Michigan Ave., Columbus, OH, United States, 43215
- Owner or operator
- REX Implants, Inc (10056452)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 20, 2020
- Registered through
- 2026
- Brand names listed
- PiezoImplant System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Blade-Form Endosseous Dental Implant | NRQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 12, 2022 | K211872 | PiezoImplant System | NRQ | Substantially Equivalent | Rex Implants, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Instruments, Dental Hand
Updated October 12, 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.