Not currently registered with FDA under this name
Shiva Products
Palghar, India. Named as applicant on 1 dental 510(k) clearance between 2024 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12024–2024
- Markets registered in
- 658 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Shiva Products as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Shiva Products | 1 clearances | 2024–2024 | Below |
| India | CDSCO | Registration holder | Shiva Products | 45 | 2022–2024 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Shiva ProductsShiva products | 9 | 2023–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Shiva Products | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHIVA PRODUCTS | 1 | 2023–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | shiva products | 1 | 2015–2015 | 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
510(k) clearances
Clearances on which FDA names Shiva Products as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Jul 2024 | K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: Aadi Med Private Limited (1).
Sources
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 of the most recent filing, which can be a US agent.