Data / Medical devices / United States / Digital Arches Inc.
Digital Arches Inc.: FDA-registered device maker in Fountain Valley, CA, United States, 2 510(k) clearances
Digital Arches Inc. is registered with the FDA (registration 3035983708) in Fountain Valley, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035983708
- Address
- 17197 Newhope St Ste J, Fountain Valley, CA, United States, 92708
- Owner or operator
- Digital Arches Inc. (10092998)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- June 3, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Complaint file establishment | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | 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 |
|---|---|---|---|---|---|---|
| March 14, 2025 | K243353 | One-Fil Putty | KIF | Substantially Equivalent | Mediclus Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K214003 | Dental Zirconia Pre-shaded Block | EIH | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Drill, Dental, Intraoral
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Resin, Root Canal Filling
Updated March 14, 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.