Manufacturer registered with FDA
Hunan Hualian Special Ceramics Co., Ltd
Zhuzhou, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 188
- 510(k) clearances
- 12024–2024
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Hunan Hualian Special Ceramics Co., Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hunan Hualian Special Ceramics Co., Ltd | 1 clearances | 2024–2024 | Below |
| Brazil | ANVISA | Manufacturer | HUNAN HUALIAN SPECIAL CERAMICS CO., LTD | 1 | 2025–2025 | 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 Hunan Hualian Special Ceramics 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Zirconia BlockDental Zirconia Block (Models HT, ST, SHT, UT, 3D-Pro,4D-Max)HT A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30) 178 moreHT B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)HT White D98/D95/92*75(Thickness: 10,12,14,16,18,20,22,25,30)Powder, PorcelainSHT A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT ML-D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)SHT White D98/D95/92*75(Thickness: 10,12,14,16,18,20,22,25,30)ST A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST ML-D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)ST White D98/D95/92*75(Thickness: 10,12,14,16,18,20,22,25,30)UT A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-A3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-A3.5 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-A4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-B1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-B2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-B3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-B4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-BL1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-BL2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-BL3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-BL4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-C1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-C2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-C3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-C4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-D2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-D3 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT ML-D4 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)UT White D98/D95/92*75(Thickness: 10,12,14,16,18,20,22,25,30)Zirconia Block3D-Pro ML-A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30)3D-Pro ML-A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30) | 2024 |
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 |
|---|---|---|
| HUNAN HUALIAN SPECIAL CERAMICS CO., LTDFDA reg. 3034605324 | Zhuzhou Hunan, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091994). 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.