Data / Medical devices / United States / Archy Dental, Inc.
Archy Dental, Inc.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
Archy Dental, Inc. is registered with the FDA (registration 3042655017) in San Jose, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042655017
- Address
- 3031 Tisch Way 110 Plz. W., San Jose, CA, United States, 95128
- Owner or operator
- Archy Dental, Inc. (10096232)
- Roles
- Manufacturer
- First device listed
- July 31, 2026
- Registered through
- 2026
- Brand names listed
- Archy Dental Imaging
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| November 21, 2025 | K251880 | Archy Dental Imaging | LLZ | Substantially Equivalent | Archy Dental, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 21, 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.