Erran Dental Zirconia— 510(k) K182068

Name: FDA 510(k) clearance K182068
Creator: U.S. Food and Drug Administration
Published: 2018-12-13

Substantially Equivalent

Hangzhou Erran Technology Co., Ltd.

FDA 510(k) clearance K182068 for Erran Dental Zirconia, Substantially Equivalent on 2018-12-13. Applicant: Hangzhou Erran Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Erran Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2018-08-01
Decision date: 2018-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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K260918 — Zolid Lunaris2026-06-29

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