Manufacturer registered with FDA
J C India
Rajkot, India. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 219 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name J C India 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 | J C India | 5 device types | — | Below |
| India | CDSCO | Registration holder | JC INDIA | 19 | 2025–2025 | 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 J C India currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Rainbow preformed space maintainer | 2026 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Rainbow Bio CERRainbow CALRainbow CAL I,Rainbow MTA Putty | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | RAINBOW BLUE FLEX FILES | 2026 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Rainbow LC CALRainbow LC GIC | 2026 |
| Preformed CrownELZ · Class 1 | — | Maker | Rainbow preformed Gold primary and permanent crownsRainbow preformed Rose gold primary and permanent crownsRainbow preformed ZR crowns | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| J C INDIAFDA reg. 3045853414 | Rajkot Gujarat, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095838). 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.