FDA applicant
S.I.N. - Sistema DE Implante Nacional S.A.
FDA records 18 decisions for S.I.N. - Sistema DE Implante Nacional S.A. (São Paulo, BR) from 2005 to 2024: 18 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 222 for FDA’s reviews in the same codes and years. Its devices cite 52 predicates, 32 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “S.I.N. – Sistema DE Implante Nacional S.A.”, “Sin Sistema DE Implante Nacional Ltda”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided S.I.N. - Sistema DE Implante Nacional S.A.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like S.I.N. - Sistema DE Implante Nacional…’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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