Manufacturer registered with FDA
Beyond International Inc.
Sugar Land, TX, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 534 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Beyond International Inc. 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 | Beyond International Inc. | 3 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Beyond International Inc. | 13 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Beyond International Inc. | 9 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BEYOND INTERNATIONAL INC. | 6 | 2022–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BEYOND INTERNATIONAL INC. | 6 | 2017–2025 | 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 Beyond International Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | — | 2009 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | — | 2009 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | BY-M015 BEYOND® FlexiPro Cheek Retractor (5 Pack)BY-M016 BEYOND® FlexiPro Cheek Retractor (Single Pack) | 2009 |
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 |
|---|---|---|
| Beyond International Inc.FDA reg. 3005791808 | Sugar Land, TX, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030042). 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.