Manufacturer registered with FDA
HyperCert Limited
Lewes, DE, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 427 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name HyperCert Limited 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 | HyperCert Limited | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Joydenta Dental Laboratory | 13 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Joydenta Dental Laboratory | 12 | 2026–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | JOYDENTA DENTAL LABORATORY | 2 | 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 HyperCert Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Basic retainerBleaching retainerEcodont retainerFinishing retainerFixed RetainerSmartfix retainer | 2025 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | arylic denturesE.max crown/bridgemetal framework denturesPorcelain fused to metal crown/bridgesValplastzirconia | 2025 |
| Preformed CrownELZ · Class 1 | — | Maker | Prefabricated Crown | 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 |
|---|---|---|
| Joydenta Dental LaboratoryFDA reg. 3039432369 | Shenzhen Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Other names on FDA records
Joydenta Dental Laboratory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093279). 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.