Manufacturer registered with FDA
Sprig Oral Health Technologies, Inc.
Rocklin, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12023–2023
- Markets registered in
- 519 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Sprig Oral Health Technologies, 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 | Sprig Oral Health Technologies, Inc. | 1 clearances | 2023–2023 | Below |
| Canada | Health Canada | Registration holder | SPRIG ORAL HEALTH TECHNOLOGIES, INC. | 16 | 2013–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | SPRIG Oral Health Technologies | 1 | 2019–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sprig Oral Health Technologies, Inc | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Sprig Oral Health Technologies, Inc. | 1 | — | 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 Sprig Oral Health Technologies, 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 |
|---|---|---|---|---|
| Preformed CrownELZ · Class 1 | — | Maker | Sprig Oral Health Technologies, Inc. | 2011 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | SmartMTA Capsule | 2023 |
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
Sprig Oral Health Technologies, 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: Ez-Pedo, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Jun 2009 | K091362 | CERAMIC PEDATRIC PREFORMED CROWN | Ez-Pedo, Inc. | ELZ Preformed Crown |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Sprig Oral Health Technologies, Inc.FDA reg. 3009133627 | Rocklin, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037769). 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.