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510(k) Data Aggregation
K Number
K182329Device Name
SureCure Orthodontic Aligner System
Manufacturer
Digital Orthodontic Care
Date Cleared
2018-11-08
(72 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Digital Orthodontic Care
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureCure Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
Device Description
Digital Orthodontic Care's SureCure Orthodontic Aligner System consists of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
Digital Orthodontic Care manufactures the customized aligners based on either standard impressions or intraoral scans sent to the company by the prescribing dentist or orthodontist. Digital Orthodontic Care manufactures models from the impressions and those models are scanned using standard validated software. The digital files are used to produce the aligner series with the thermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.
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