Data / Medical devices / India / Septodont Healthcare India Private Ltd.
Septodont Healthcare India Private Ltd.: FDA-registered device maker in VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, India, 2 510(k) clearances
Septodont Healthcare India Private Ltd. is registered with the FDA (registration 3004443427) in VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, India. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 13, 2018. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004443427
- Address
- C-1/2 Midc Industrial Area Taloja, VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, India, 410208
- Owner or operator
- SEPTODONT (8010102)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 10, 2009
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 13, 2018 | K172839 | ENDOSOLV | KIF | Substantially Equivalent | Septodont | accessdata.fda.gov |
| November 20, 2003 | K032708 | PLASTALGIN AND PLASTALGIN ORTHO | ELW | Substantially Equivalent | Septodont | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2018. 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.