Data / Medical devices / India / Kids-E-Dental LLP
Kids-E-Dental LLP: FDA-registered device maker in Mumbai Maharashtra, India, 1 510(k) clearance
Kids-E-Dental LLP is registered with the FDA (registration 3020703838) in Mumbai Maharashtra, India. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020703838
- Address
- 411, Akruti Arcade, Jp Road, Opp. A.H. Wadia School Andheri West, Mumbai Maharashtra, India, 400053
- Owner or operator
- Kids-E-Dental LLP (10082787)
- Roles
- Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- October 5, 2021
- Registered through
- 2026
- Brand names listed
- Bioflx Crown, Kids-e-SSC, Kids-e-crown, e- crimper, e-Cutter, e-SDF, e-space maintainer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown, Preformed | ELZ | 1 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Diammine Silver Fluoride Dental Hypersensitivity Varnish | PHR | 2 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 6, 2024 | K240619 | e-SDF | PHR | Substantially Equivalent | Kids-E-Dental Llp | accessdata.fda.gov |
Compare with other makers
- All makers of Crown, Preformed
- All makers of Diammine Silver Fluoride Dental Hypersensitivity Varnish
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Plier, Orthodontic
Updated March 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.