510(k) Report

FDA applicant

Ortho Source

North Hollywood, CA9 decisions1986–19920 recalls

FDA records 9 decisions for Ortho Source (North Hollywood, CA) from 1986 to 1992: 9 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and EBC (Sealant, Pit And Fissure, And Conditioner). 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 Ortho Source’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortho Source since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ortho”

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