Data / Medical devices / United States / Xtechdental Inc
Xtechdental Inc: FDA-registered device maker in Fort Lee, NJ, United States, 2 510(k) clearances
Xtechdental Inc is registered with the FDA (registration 3045129740) in Fort Lee, NJ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045129740
- Address
- 1605 John St Ste 203, Fort Lee, NJ, United States, 07024
- Owner or operator
- XTECHDENTAL INC (10095904)
- Roles
- Complaint file establishment
- First device listed
- May 19, 2026
- Registered through
- 2026
- Brand names listed
- Dental Computed Tomography X-ray System, Digital Intraoral Imaging Plate System, F200 IMAGE PLATE SYSTEM, Matrix7000, Matrix7800, Rubik Series CBCT, Rubik X1, Rubik X3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| November 13, 2025 | K251842 | Dental Computed Tomography X-ray System | OAS | Substantially Equivalent | Fussen Technology Co., Ltd. | accessdata.fda.gov |
| December 5, 2019 | K192766 | Digital Intraoral Imaging Plate System | MUH | Substantially Equivalent | Fsusen Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of X-Ray, Tomography, Computed, Dental
Updated November 13, 2025. 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.