Registered with FDA
Sterlab
VALLAURIS, France. Lists 4 dental device types with FDA across 2 registered establishments.
- Device types listed
- 4
- Brands and models
- 19
- 510(k) clearances
- 0as applicant
- Markets registered in
- 520 registrations outside the US
- Establishments
- 2France
Registered in 5 markets
Where regulators' registries name Sterlab 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 | Sterlab | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | STERLAB | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Sterlab | 4 | 2014–2014 | Pure Global AI |
| Israel | AMAR | Manufacturer | STERLAB | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | STERLAB | 1 | 2025–2025 | 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 Sterlab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | K-REAMERS | 2014 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | HYFLEX REMOVERMicromega One curve Mini (sterile)Micromega One Curve Mini procedure pack (sterile)Micromega One Gilder (sterile)Micromega One Reci (sterile)Micromega One Reci Procedure pack (sterile)Micromega Reci Gilder (sterile)MICROMEGA REMOVERMM TAPERONE CURVE 6 moreONE CURVE PROCEDURE PACKONE FLAREONE G2 SHAPE2 SHAPE Procedure pack2Shape Mini | 2014 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | Accessories for oral irrigation, various tubes | 2013 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | FINGER SPREADER | 2014 |
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 |
|---|---|---|
| STERLABFDA reg. 3006174295 | SIGNES Var, France | Contract sterilizer |
| STERLABFDA reg. 1000286794 | VALLAURIS Alpes-Maritimes, France | Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042816). 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.