Data / Medical devices / India / Aadi Med Private Limited
Aadi Med Private Limited: FDA-registered device maker in Dist. Palghar Maharashtra, India, 1 510(k) clearance
Aadi Med Private Limited is registered with the FDA (registration 3008822460) in Dist. Palghar Maharashtra, India. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 30, 2024. Registered through 2026. FDA data exported November 2, 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
- 3008822460
- Address
- B-18, Dwarka Industrial Estate, Naikpada, Waliv, Vasai (East), Vasai Virar, Dist. Palghar Maharashtra, India, 401208
- Owner or operator
- Aadi Med Private Limited (10094799)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 24, 2025
- Registered through
- 2026
- Brand names listed
- Calahyd-RC (1.5g x 2 syr), Calcium Hydroxide powder (15g, 30g, 100g), Calx-O (1.5gm x 2 syr.), Ceraseal-B (1g + 5ml), Endo Paste, Endogel-RC, Endo-L, Green Tracing Sticks / Impression Compound sticks, Impression Compound Cakes, MAARC Base Plate Wax and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Plaque Disclosing Agent | QJC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Reliner, Denture, Over The Counter | EBP | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 30, 2024 | K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | KIF | Substantially Equivalent | Shiva Products | accessdata.fda.gov |
Compare with other makers
- All makers of Denture Preformed (Partially Prefabricated Denture)
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Preparer, Root Canal Endodontic
- All makers of Resin, Root Canal Filling
- All makers of Zinc Oxide Eugenol
- All makers of Reliner, Denture, Over The Counter
Updated July 30, 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.