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510(k) Data Aggregation
K Number
K223338Device Name
Toothsi, Smilealigners
Manufacturer
Date Cleared
2023-02-09
(100 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Makeo Healthcare Technologies Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.
Device Description
The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.
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