Manufacturer registered with FDA
Kids-E-Dental LLP
Mumbai, India. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 12024–2024
- Markets registered in
- 960 registrations outside the US
- Establishments
- 1India
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Kids-E-Dental LLP 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 | Kids-E-Dental LLP | 1 clearances | 2024–2024 | Below |
| India | CDSCO | Registration holder | KIDS-E-DENTAL LLPKids-e-Dental LLP | 22 | 2023–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | KIDS-E-DENTAL LLP | 19 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KIDS-E-DENTAL LLP | 9 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KIDS-E-DENTAL LLP | 5 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Kids-e-DentalKids-e-Dental LLP | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Kids-e-Dental LLP | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Kids-e-Dental LLP | 1 | 2026–2026 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Kids-e-Dental LLP | 1 | 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 Kids-E-Dental LLP 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 | e-space maintainer | 2021 |
| Preformed CrownELZ · Class 1 | — | Maker | Bioflx CrownKids-e-crownKids-e-SSC | 2021 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | e- crimpere-Cutter | 2021 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Maker | e-SDF | 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 Kids-E-Dental LLP as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Mar 2024 | K240619 | e-SDF | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
Some of these clearances are listed with FDA today by another company: NuSmile, Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KIDS-E-DENTAL LLPFDA reg. 3020703838 | Mumbai Maharashtra, India | Manufacturer, Private-label distributor, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10082787). 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.