HCG Zirconia Ceramic Block— 510(k) K193090

Substantially Equivalent

Hocheng Corporation

FDA 510(k) clearance K193090 for HCG Zirconia Ceramic Block, Substantially Equivalent on 2020-10-29. Applicant: Hocheng Corporation. Device class: 2.

Clearance details

Applicant: Hocheng Corporation
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2019-11-06
Decision date: 2020-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
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.