FDA applicant
BCS Device Pte., Ltd.
FDA records 1 decision for BCS Device Pte., Ltd. (Singapore, SG) in 2026: 1 510(k) clearance. All are in product code KIF (Resin, Root Canal Filling). 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 BCS Device Pte., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026high 1 (2026)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like BCS Device Pte., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report