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510(k) Data Aggregation
K Number
K210763Device Name
Inman Digital Clear Aligners
Manufacturer
Date Cleared
2021-09-29
(198 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Inman Orthodontic Laboratories, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Inman Digital Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The Inman Digital Clear Aligners position teeth by way of continuous gentle force.
Device Description
The Inman Digital Clear Aligners consist of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane. A dental clinician prescribes the aligners based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are provided to Inman Orthodontic Lab by the dental clinician, along with the prescription. The series of plastic aligner trays are designed according to the prescription using standard dental software for planning the tooth alignments. The software used is 3Shape Ortho System (Reference device K152086). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models. After the plan is developed by Inman Orthodontic Lab, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, the customized aligner trays are fabricated by Inman Orthodontic Lab by press thermoforming of the material on the molds using standard thermoforming equipment. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.
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