Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)— 510(k) K253053

Name: FDA 510(k) clearance K253053
Creator: U.S. Food and Drug Administration
Published: 2025-09-23

Substantially Equivalent

Hangzhou SHINING3D Dental Technology Co., Ltd.

FDA 510(k) clearance K253053 for Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1), Substantially Equivalent on 2025-09-23. Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2025-09-22
Decision date: 2025-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Hangzhou SHINING3D Dental Technology Co., Ltd.

view all

K261356 — Dura-Crown2026-04-27
K261261 — Dura-Arch2026-04-17
K260170 — LumiCera2026-01-21
K250946 — Denture Base Resin DT202025-03-31

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