FDA applicant
Reliance Orthodontic Products, Inc.
FDA records 32 decisions for Reliance Orthodontic Products, Inc. (Itasca, IL) from 1988 to 2021: 32 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 8 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 Reliance Orthodontic Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Reliance Orthodontic Products, Inc.’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) ReportOther applicant names beginning “Reliance”
FDA records each applicant name separately; these may or may not be the same firm.