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510(k) Data Aggregation
K Number
K212496Device Name
Ortho Aligner System
Manufacturer
Ortho Lab Services, LLC
Date Cleared
2021-11-04
(87 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Ortho Lab Services, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortho Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Ortho Aligner System positions teeth by way of continuous gentle force.
Device Description
The Ortho Aligner System is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental practitioner's prescription.
Physical impressions or digital intraoral scans of the patient's teeth are provided to Ortho Lab Services. A treatment plan consisting of 3D models is created from the impressions or scans, by Ortho Lab Services using the OrthoWare software. Upon approval of the treatment plan by the treating dental practitioner using OrthoPortal and issuance of an electronic prescription, the clear aligners are manufactured using thermoforming methods.
The finished, customized aligners are shipped based on the dental practitioner's order and confirmed for patient fit and design.
The aligner trays are held in place by pressure and can be removed by the patient at any time.
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