Dental Glass Ceramics— 510(k) K232673

Name: FDA 510(k) clearance K232673
Creator: U.S. Food and Drug Administration
Published: 2024-01-23

Substantially Equivalent

Chengdu Besmile Medical Technology Co., Ltd.

FDA 510(k) clearance K232673 for Dental Glass Ceramics, Substantially Equivalent on 2024-01-23. Applicant: Chengdu Besmile Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chengdu Besmile Medical Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2023-09-01
Decision date: 2024-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chengdu, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

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

More clearances from Chengdu Besmile Medical Technology Co., Ltd.

view all

K252286 — BIORES Dental Implant System2026-02-02
K242768 — Customized Abutment and Screw2025-09-02
K232682 — Pre-Sintered Zirconia Coloring Liquid2024-03-19
K232676 — Dental Porcelain Powder2024-01-23

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