Manufacturer registered with FDA
Sota Precision Optics, Inc.
Orange, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 22003–2006
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Devices listed with FDA
What Sota Precision Optics, 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 |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Claris i310Claris i310D | 2008 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Clio PedoClio Prime | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Claris i5HD | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Sota Precision Optics, Inc. as the applicant.
Also lists devices cleared under other names
Sota Precision Optics, 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: Sota Precision Optics, Inc. Dba Sota Imaging (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Nov 2020 | K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOTA PRECISION OPTICS, INC.FDA reg. 3000190675 | ORANGE, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057540). 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.