FDA applicant
Mis Implants Technologies, Ltd.
FDA records 13 decisions for Mis Implants Technologies, Ltd. (Bar Lev Industrial Park, IL) from 2001 to 2019: 13 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 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 Mis Implants Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mis Implants Technologies, 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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