Registered with FDA
Stephens Instruments
Lexington, KY, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 111,077 registrations outside the US
- Establishments
- 1United States
Registered in 11 markets
Where regulators' registries name Stephens Instruments as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Stephens Instruments | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Stephens Instruments | 991 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Stephens InstrumentsSTEPHENS INSTRUMENTS | 30 | 2001–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Stephens Instruments | 27 | 2014–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | STEPHENS INSTRUMENTS, INC | 14 | 2024–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Stephens Instruments, Inc. | 10 | — | Pure Global AI |
| China | NMPA | Registration holder | 斯蒂芬医疗器械公司Stephens Instruments | 1 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | STEPHENS INSTRUMENTS | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Stephens Instruments | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STEPHENS INSTRUMENTS | 1 | 2006–2006 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Stephens Instruments | 1 | — | 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 Stephens Instruments currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Syringe Cannula | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| STEPHENS INSTRUMENTS, INCFDA reg. 1045379 | LEXINGTON, KY, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1045379). 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.