Manufacturer registered with FDA
Rialto Enterprises Private Limited
INDIA, India. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 258 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Rialto Enterprises Private Limited 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 | Rialto Enterprises Private Limited | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | RIALTO ENTERPRISES PVT. LTDA.RIALTO ENTERPRISES PVT.LTD. · RIALTO ENTERPRISES PVT.LTD., · +2 | 58 | — | 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 Rialto Enterprises Private Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2009 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Oral-B Kids Battery Toothbrush-DB3 | 2023 |
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 |
|---|---|---|
| RIALTO ENTERPRISES PRIVATE LIMITEDFDA reg. 3007842535 | INDIA Tamil Nadu, India | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030119). 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.