FDA applicant
Chengdu Besmile Medical Technology Co., Ltd.
FDA records 5 decisions for Chengdu Besmile Medical Technology Co., Ltd. (Chengdu, CN) from 2024 to 2026: 5 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 194 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 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 Chengdu Besmile Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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