Data / Medical devices / United States / Trate LLC
Trate LLC: FDA-registered device maker in Tamarac, FL, United States, 1 510(k) clearance
Trate LLC is registered with the FDA (registration 3030690317) in Tamarac, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030690317
- Address
- 7737 N University Drive Suite 101, Tamarac, FL, United States, 33321
- Owner or operator
- ROOTT LLC (10090363)
- Roles
- Specification developer
- First device listed
- March 18, 2024
- Registered through
- 2026
- Brand names listed
- TRATE DENTAL IMPLANT SYSTEM, TRATE DENTAL IMPLANT SYSTEM - ROOT IMPLANT AND ABUTMENT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| April 4, 2022 | K220022 | TRATE Dental Implant System | DZE | Substantially Equivalent | Trate AG | accessdata.fda.gov |
Compare with other makers
Updated April 4, 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.