Manufacturer registered with FDA
Alta Smiles, Inc
Fort Washington, PA, United States. Lists 19 dental device types with FDA across 1 registered establishment.
- Device types listed
- 19
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Alta Smiles, Inc currently lists, by FDA device type, with the brand and model names on the listing.
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
Alta Smiles, 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: Sms Opco, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Jun 2021 | K210652 | 6MS Invisible Aligner | Sms Opco, LLC | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ALTA SMILES, LLCFDA reg. 3017138012 | Fort Washington, PA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090088). 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.