Manufacturer registered with FDA
Digital Arches Inc.
Fountain Valley, CA, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Digital Arches Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2025 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | — | 2026 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | — | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Digital Arches Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Mediclus Co., Ltd (1), Shenzhen Yurucheng Dental Materials Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Mar 2025 | K243353 | One-Fil Putty | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 18 Feb 2022 | K214003 | Dental Zirconia Pre-shaded Block | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIGITAL ARCHES INC.FDA reg. 3035983708 | Fountain Valley, CA, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092998). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.