Manufacturer registered with FDA
Ceragroup Industries
Fort Lauderdale, FL, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Ceragroup Industries 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 | Ceragroup Industries | 3 device types | — | Below |
| China | NMPA | Registration holder | 喜乐特公司CERAGROUP INDUSTRIES | 1 | — | 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 Ceragroup Industries currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | — | 2004 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | C-MIXCeratecCGICrystalCeram | 2009 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | Cerakast | 2000 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Ceragroup Industries lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: C-Mix (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CERAGROUP INDUSTRIESFDA reg. 1064583 | Fort Lauderdale, FL, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9040880). 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.