Data / Medical devices / United States / Rodo Medical, Inc
Rodo Medical, Inc: FDA-registered device maker in Troy, MI, United States, 3 510(k) clearances
Rodo Medical, Inc is registered with the FDA (registration 3009742323) in Troy, MI, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009742323
- FEI number
- 3009113203
- Address
- 1010 Naughton Dr, Troy, MI, United States, 48083
- Owner or operator
- RODO Medical, Inc. (10044830)
- Roles
- Manufacturer
- First device listed
- April 29, 2015
- Registered through
- 2026
- Brand names listed
- Rodo Abutment Accesories, Rodo Abutment System, Rodo Smileloc, Smileclip, Smilekey
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Anchor, Preformed | EJX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 27, 2020 | K193274 | Rodo Abutment System | NHA | Substantially Equivalent | Rodo Medical, Inc. | accessdata.fda.gov |
| May 23, 2018 | K180609 | Rodo Smilekey | NHA | Substantially Equivalent | Rodo Medical, Inc. | accessdata.fda.gov |
| November 21, 2016 | K160786 | RODO Abutment System | NHA | Substantially Equivalent | Rodo Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Anchor, Preformed
- All makers of Accessories, Implant, Dental, Endosseous
Updated February 27, 2020. 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.