Manufacturer registered with FDA
Hexa Ceram Co., Ltd.
Sansai, Thailand. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Thailand
Devices listed with FDA
What Hexa Ceram Co., 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 |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Blue Series EFPink Series EFPink Series with DentiTracRespire Blue SeriesRespire Pink AT (Hard, Hard/Soft, EF)Respire Pink Series - Herbst | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Customized AbutmentNC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN; NNC Variobase Abutment, with screw, D 55mm, H 4mm | 2025 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | PRE Rapid Palatal Expander | 2025 |
| Sleep Appliances with Patient MonitoringPLC · Class 2 | — | Maker | Pink Series with DentiTrac | 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 |
|---|---|---|
| HEXA CERAM CO., LTD.FDA reg. 3004748290 | Sansai Chiang Mai, Thailand | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092580). 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.