Zirconia Dental Ceramics— 510(k) K170894

Name: FDA 510(k) clearance K170894
Creator: U.S. Food and Drug Administration
Published: 2017-08-01

Substantially Equivalent

Chengdu Besmile Biotechnology Co., Ltd.

FDA 510(k) clearance K170894 for Zirconia Dental Ceramics, Substantially Equivalent on 2017-08-01. Applicant: Chengdu Besmile Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chengdu Besmile Biotechnology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2017-03-27
Decision date: 2017-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chengdu, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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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

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