FDA applicant
World Bio Tech Co., Ltd.
FDA records 2 decisions for World Bio Tech Co., Ltd. (Seongnam-Si, KR) from 2012 to 2016: 2 510(k) clearances. All are in product code NJM (Bracket, Ceramic, Orthodontic). Its devices cite 2 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 World Bio Tech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like World Bio Tech Co., 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