K233125

Zirconia Block

510(k) number
K233125
Device name
Zirconia Block
Applicant
Hangzhou Ivista Medical Devices Co., Ltd. CN
Product code
EIH — Powder, Porcelain
Decision date
2024-01-12
Date received
2023-09-27
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K233125.pdf

Official FDA record: K233125
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.