FDA applicant
Hangzhou SHINING3D Dental Technology Co., Ltd.
FDA records 5 decisions for Hangzhou SHINING3D Dental Technology Co., Ltd. (Hangzhou, CN) from 2025 to 2026: 5 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Since 2016 its 510(k)s took a median of 2 days from receipt to decision, against 59 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hangzhou SHINING3D Dental Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
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