Manufacturer registered with FDA

Zhejiang Zahndent Biotechnology Co.,Ltd

Taizhou, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10091053Manufacturer1 clearance in five years
Device types listed
1
Brands and models
1
510(k) clearances
12024–2024
Markets registered in
1United States
Establishments
1China
2024: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Zhejiang Zahndent Biotechnology Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
2024

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 Zhejiang Zahndent Biotechnology Co.,Ltd as the applicant.

Decided510(k)DeviceDevice type
7 Jun 2024K240672Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)EIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTDFDA reg. 3031595584Taizhou Zhejiang, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10091053). 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.