Manufacturer registered with FDA
Perimetrics, Inc
Redmond, WA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 32008–2025
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Perimetrics, Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Perimetrics, Inc | 3 clearances | 2008–2025 | Below |
| Canada | Health Canada | Registration holder | PERIMETRICS, INC | 3 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Perimetrics Inc | 2 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Perimetrics, 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 |
|---|---|---|---|---|
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | InnerView 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
510(k) clearances
Clearances on which FDA names Perimetrics, Inc as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PERIMETRICS, INCFDA reg. 3039642990 | Santa Ana, CA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9058882). 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.