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PREORTHO Pre-Orthodontic Device

FOREST-ONE CO., LTD. · Model T3-MH · UDI-DI 04573443678823

KMY Prescription

510(k) clearances

1,674

Adverse events

Recalls

112

Facilities

Description

An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, designed to influence the shape and or function of the stomatognathic system to correct malocclusions, e.g., underbites, overbites, cross bites, open bites, crooked teeth, and or structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.