Dental Ceramic— 510(k) K182350

Name: FDA 510(k) clearance K182350
Creator: U.S. Food and Drug Administration
Published: 2019-05-22

Substantially Equivalent

Baot Biological Technology Co., Ltd.

FDA 510(k) clearance K182350 for Dental Ceramic, Substantially Equivalent on 2019-05-22. Applicant: Baot Biological Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Baot Biological Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2018-08-29
Decision date: 2019-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.