FDA applicant
Dmetec.Co., Ltd.
FDA records 5 decisions for Dmetec.Co., Ltd. (Great Neck, NY) from 2005 to 2017: 5 510(k) clearances. Most are in product codes DZI (Drill, Bone, Powered) and ELC (Scaler, Ultrasonic). Its devices cite 8 predicates, 1 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 Dmetec.Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dmetec.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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