FDA applicant
S-Denti Co., Ltd.
FDA records 4 decisions for S-Denti Co., Ltd. (Greenwood Village, CO) from 2009 to 2012: 4 510(k) clearances. All are in product code LQY (Locator, Root Apex). Its devices cite 3 predicates, 3 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 S-Denti Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2012
2009high 2 (2012) · low 0 (2011)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like S-Denti 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