Search Results
Found 1 results
510(k) Data Aggregation
K Number
K222918Device Name
DentCare Aligners
Manufacturer
Date Cleared
2022-11-25
(60 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DentCare Dental Lab Pvt Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DentCare Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligner guide teeth to their final position by way of continuous gentle forces.
Device Description
The DentCare Aligners are transparent medical grade thermoplastic materials moulded for the use in orthodontic alignment of teeth from one position to another. The DentCare Aligners are used in correcting various malocclusions. Hence it requires precise treatment planning before fabrication. Thorough understanding of the process and steps are required before proceeding to provide a successful aligner treatment.
Ask a Question
Ask a specific question about this device
Page 1 of 1