Manufacturer registered with FDA
Aadi Med Private Limited
Vasai, India. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 594 registrations outside the US
- Establishments
- 1India
Registered in 5 markets
Where regulators' registries name Aadi Med 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 | Aadi Med Private Limited | 10 device types | — | Below |
| India | CDSCO | Registration holder | Aadi Med Pvt. LtdAadi Med Private Limited | 61 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Aadi Med Private Limited | 23 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Aadi Med Private Limited | 9 | 2024–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Aadi Med Private Limited | 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 Aadi Med 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 |
|---|---|---|---|---|
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | Soft Liner | 2026 |
| Shellac Base PlateEEA · Class 1 | — | Maker | Green Tracing Sticks / Impression Compound sticksImpression Compound CakesShellac Base Plate - All types and thicknessSpecial Tray BlanksSpecial Tray Plates (STP) for preparing custom trays | 2026 |
| Articulation PaperEFH · Class 1 | — | Maker | MAARC Dental Articulating Paper | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | MAARC Base Plate Wax | 2025 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Pro-PastePumice powder (Different Grits)Saphire (Diamond Polishing Paste)Zirprophy | 2026 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | Re-Inforcement Mesh (Golden / Silver) | 2026 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Endo Paste, Endogel-RC, Endo-L | 2026 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | ZOE Impression Paste, Zinc Oxide Powder, Eugenol, Ziego | 2026 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Calahyd-RC (1.5g x 2 syr)Calcium Hydroxide powder (15g, 30g, 100g)Calx-O (1.5gm x 2 syr.)Ceraseal-B (1g + 5ml)MTA (1g + 5ml, 500mg+5ml, 180mg+2ml)Rootfyx (0.5g x 4 syr, 1g x 4 syr.)Sealmax + (2g + 4ml, 3g + 5ml)Sealmax-R (10g+10ml) | 2025 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | PLAQUE-D | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Aadi Med Private Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Shiva Products (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Jul 2024 | K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Aadi Med Private LimitedFDA reg. 3008822460 | Dist. Palghar Maharashtra, India | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094799). 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.