FDA applicant
Biocetec Co., Ltd.
FDA records 4 decisions for Biocetec Co., Ltd. (Seoul, KR) from 2017 to 2023: 4 510(k) clearances. Most are in product codes NJM (Bracket, Ceramic, Orthodontic) and OAT (Implant, Endosseous, Orthodontic). Since 2016 its 510(k)s took a median of 173 days from receipt to decision, against 192 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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 Biocetec Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Biocetec Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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