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510(k) Data Aggregation
K Number
K173785Device Name
Custom Clear Aligner System
Manufacturer
Derby Dental Laboratory
Date Cleared
2018-03-13
(90 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Derby Dental Laboratory
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Custom Clear Aligner System is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
Device Description
Derby Dental Laboratory's Custom Clear Aligner System contains a series of doctor-approved, customized processed, clear plastic removable aligners that gradually move the patient's teeth in small increments from their original misalignment to a more optimal, aligned and treated stated.
Derby Dental Laboratory manufactures the customized aligners based on standard impressions sent to the company by the prescribing dentist or orthodontist. These are made after the clinician has assessed the patient's teeth, designed a treatment plan, and taken the impressions.
Derby Dental manufactures models from the impressions and then scans the models using standard validated software. The digital files are used to produce the aligner series using standard thermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances.
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