Dura-Arch— 510(k) K261261

Name: FDA 510(k) clearance K261261
Creator: U.S. Food and Drug Administration
Published: 2026-04-17

Substantially Equivalent

Hangzhou SHINING3D Dental Technology Co., Ltd.

FDA 510(k) clearance K261261 for Dura-Arch, Substantially Equivalent on 2026-04-17. Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2026-04-16
Decision date: 2026-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

view all

K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22
K243951 — TEMP MASTER, PMMA-based dental resin2025-02-21

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

view all

K261356 — Dura-Crown2026-04-27
K260170 — LumiCera2026-01-21
K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)2025-09-23
K250946 — Denture Base Resin DT202025-03-31

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