K240672

Dental 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)

510(k) number
K240672
Device name
Dental 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)
Applicant
Zhejiang Zahndent Biotechnology Co., Ltd. CN
Product code
EIH — Powder, Porcelain
Decision date
2024-06-07
Date received
2024-03-11
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K240672.pdf

Official FDA record: K240672
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.