Manufacturer registered with FDA
Perflex Ltd
Netanya, Israel. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 12015–2015
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Perflex Ltd 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 | Perflex Ltd | 1 clearances | 2015–2015 | Below |
| Canada | Health Canada | Registration holder | PERFLEX LTD. | 2 | 2017–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | Perflex Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Perflex LTD | 1 | 2015–2015 | 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 Perflex Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Thermofix , BDImpress | 2014 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | ACRYFREE BIOSENS FLEXINYLONT-Crystal | 2015 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | Flexiclean | 2015 |
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 |
|---|---|---|
| PERFLEX LTDFDA reg. 3011532731 | Netanya Central, Israel | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048177). 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.