Manufacturer registered with FDA
Shimmer Computerized Dental Technology Co.,LTD
Zhuhai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shimmer Computerized Dental Technology Co.,LTD 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 | Shimmer Computerized Dental Technology Co.,LTD | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | SHIMMER COMPUTERIZED DENTAL TECHNOLOGY CO., LTD. | 2 | 2021–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Shimmer Computerized Dental Technology Co Ltd | 1 | 2024–2024 | 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 Shimmer Computerized Dental Technology 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Dess Implant | 2025 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | Dess Implant | 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 |
|---|---|---|
| SHIMMER COMPUTERIZED DENTAL TECHNOLOGY CO.,LTDFDA reg. 3009795022 | Zhuhai Guangdong, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041865). 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.