FDA applicant
Miradent Distributing Co., LLC
FDA records 1 decision for Miradent Distributing Co., LLC (Morris Plains, NJ) in 1999: 1 510(k) clearance. All are in product code KLE (Agent, Tooth Bonding, Resin). 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 Miradent Distributing Co., LLC’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Miradent Distributing Co., LLC since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Miradent Distributing Co., LLC’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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