Manufacturer registered with FDA
Sion Biotext Medical Ltd
Sderot, Israel. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8158 registrations outside the US
- Establishments
- 1Mexico
Registered in 8 markets
Where regulators' registries name Sion Biotext Medical 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 | Sion Biotext Medical Ltd | 2 device types | — | Below |
| Israel | AMAR | Registration holder | Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTD. | 98 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SION BIOTEXT MEDICAL LTD. | 41 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Sion Biotext Medical Ltd. | 8 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SION BIOTEXT MEDICAL LTD | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Sion Biotext Medical Ltd | 3 | 2018–2023 | Pure Global AI |
| Canada | Health Canada | Registration holder | SION BIOTEXT MEDICAL LTD. | 2 | 2010–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sion Biotext Mexico, S.A.P.I. de C.V | 1 | 2026–2026 | 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 Sion Biotext Medical 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2024 |
| Roll CottonEFN · Class 1 | — | Maker | — | 2024 |
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 |
|---|---|---|
| Sion Biotext Mexico, S.A.P.I. de C.VFDA reg. 3016603542 | Jiutepec Morelos, Mexico | Contract manufacturer, Manufacturer |
Other names on FDA records
Sion Biotext Mexico, S.A.P.I. de C.V
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030128). 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.