FDA applicant
Space Maintainers Laboratories (Sml)
FDA records 1 decision for Space Maintainers Laboratories (Sml) (Chatsworth, CA) in 2024: 1 510(k) clearance. All are in product code NXC (Aligner, Sequential). Its devices cite 1 predicate, 0 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 Space Maintainers Laboratories (Sml)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Space Maintainers Laboratories (Sml)’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