Dental Glass Ceramics Blocks— 510(k) K232438

Name: FDA 510(k) clearance K232438
Creator: U.S. Food and Drug Administration
Published: 2023-12-01

Substantially Equivalent

Aibodent Biotechnology Co., Ltd.

FDA 510(k) clearance K232438 for Dental Glass Ceramics Blocks, Substantially Equivalent on 2023-12-01. Applicant: Aibodent Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aibodent Biotechnology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2023-08-14
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, 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

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