Manufacturer registered with FDA
Milestone Scientific, Inc.
Roseland, NJ, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 9
- 510(k) clearances
- 12006–2006
- Markets registered in
- 1143 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Milestone Scientific, Inc. 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 | Milestone Scientific, Inc. | 1 clearances | 2006–2006 | Below |
| Canada | Health Canada | Registration holder | MILESTONE SCIENTIFIC, INC. | 9 | 1999–2018 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | MILESTONE SCIENTIFIC, INC. | 8 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Milestone Scientific Inc.Milestone Scientific Inc | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Milestone Scientific Inc | 4 | 2003–2017 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Milestone Scientific, Inc. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MILESTONE SCIENTIFIC INC. | 3 | 2013–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Milestone Scientific, Inc.MILESTONE SCIENTIFIC | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Milestone Scientific, Inc.Milestone Scientific, Inc | 3 | 2005–2006 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Milestone Scientific, Inc. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Milestone Scientific, Inc. | 1 | 2013–2013 | 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 Milestone Scientific, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | CompuDent STA HandpieceCompuDent STA SystemCompuFlo Computer Controlled CathCheck KitCompuFlo Computer Controlled Epidural Disposable KitCompuFlo Epidural Controlled Anesthetic SystemSafety Wand Disposable HandpieceThe Wand Computer Controlled Anesthetic Delivery SystemThe Wand HandpieceThe Wand Plus System | 2007 |
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
Milestone Scientific, Inc. 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: Spintech, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Sep 2003 | K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | EJI Cartridge Syringe |
| 5 Jul 1996 | K961648 | THE WAND | Spintech, Inc. | EJI Cartridge Syringe |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MILESTONE SCIENTIFIC, INC.FDA reg. 3004082685 | Roseland, NJ, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9026774). 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.