Data / Medical devices / United States / Reset Technology Corporation
Reset Technology Corporation: FDA-registered device maker in Irving, TX, United States, 1 510(k) clearance
Reset Technology Corporation is registered with the FDA (registration 3030159375) in Irving, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030159375
- Address
- 4200 W Royal Ln Suite #125, Irving, TX, United States, 75063
- Owner or operator
- Reset Technology Corporation (10089702)
- Roles
- Repackager or relabeler
- First device listed
- December 29, 2023
- Registered through
- 2026
- Brand names listed
- Reset Impression Kit, ResetSmile Impression Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 8, 2022 | K221668 | Dental Impression Material | ELW | Substantially Equivalent | Chemoment Materials Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Retractor, All Types
- All makers of Material, Impression
Updated August 8, 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.