510(k) Report

FDA applicant

Reliance Orthodontic Products, Inc.

Itasca, IL32 decisions1988–20210 recalls

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, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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

2007: 22008: 12009: 12010: 12011: 12013: 22016: 12020: 12021: 2
2007high 2 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Reliance Orthodontic Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Reliance”

FDA records each applicant name separately; these may or may not be the same firm.