Manufacturer registered with FDA
Topzir Biotech Co., Ltd
Guangzhou, 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
- 2
- 510(k) clearances
- 12023–2023
- Markets registered in
- 1United States
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Topzir Biotech 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 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank4D Ultra Fit Multilayer, 3D Pro Ultra Multilayer | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Topzir Biotech Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Mar 2023 | K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Shofu Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TOPZIR BIOTECH CO., LTDFDA reg. 3027341558 | Guangzhou Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087795). 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.