Manufacturer registered with FDA
Archform Inc.
Santa Clara, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12021–2021
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Archform 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 |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Archform Retainer | 2024 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Form Aligners | 2016 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | ArchForm Orthodontic Software System | 2024 |
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
Archform 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: Martz, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Mar 2016 | K151965 | Dentti System | Martz, Inc. | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ARCHFORM, INC.FDA reg. 3018126402 | Santa Clara, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047382). 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.