510(k) Report

FDA applicant

Miles Inc., Dental Products

South Bend, IN2 decisions1993–19940 recalls

FDA records 2 decisions for Miles Inc., Dental Products (South Bend, IN) from 1993 to 1994: 2 510(k) clearances. Most are in product codes KQO (Automated Urinalysis System) and 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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Miles Inc., Dental Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Miles Inc., Dental Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Miles”

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