Manufacturer registered with FDA
Sion Biotext Mexico, S.A.P.I. De C.V.
Civac, Mexico. 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
- 218 registrations outside the US
- Establishments
- 1Mexico
Registered in 2 markets
Where regulators' registries name Sion Biotext Mexico, S.A.P.I. De C.V. 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 Mexico, S.A.P.I. De C.V. | 2 device types | — | Below |
| Mexico | COFEPRIS | Registration holder | SION BIOTEXT MÉXICO, S.A.P.I. DE C.V.Sion Biotext México, S.A.P.I. de C.V. · Sion Biotext México, S.A.P.I. DE C.V. | 18 | 2025–2026 | 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 Mexico, S.A.P.I. De C.V. 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 | — | 2025 |
| Roll CottonEFN · Class 1 | — | Maker | — | 2025 |
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.V.,FDA reg. 3035479692 | Civac Mexico, Mexico | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092513). 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.