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Redline

JOHN'S DENTAL LABORATORY INC · Model 3014680794 · UDI-DI 00810002220135

NXC Prescription

510(k) clearances

18,531

Adverse events (1 deaths)

Recalls

Facilities

Description

Orthodontic plastic bracket. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, 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 other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Recalls

Date	Firm	Reason
2024-11-22	3M Company - Health Care Business	Attachments may not mate with the tooth as intended in the digital treatment design.
2024-11-04	Straight Smile, LLC	Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicatio

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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.