Manufacturer registered with FDA
Septodont
Lancaster, PA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Septodont 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 | Lister | Aspiject Self-Asperating Syringe | 2019 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | — | 2013 |
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
Septodont 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: Arnold Tuber Industries (1), Ronvig Instruments, Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Dec 2009 | K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | Arnold Tuber Industries | EJI Cartridge Syringe |
| 13 Oct 2000 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | EJI Cartridge Syringe |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Septodont, IncFDA reg. 3008242564 | Lancaster, PA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005668). 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.