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510(k) Data Aggregation
K Number
K232074Device Name
Serafin®
Manufacturer
Date Cleared
2024-02-22
(225 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
TNS Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Serafin is intended for the orthodontic treatment of malocclusion.
Device Description
Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.
The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.
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