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510(k) Data Aggregation
K Number
K223029Device Name
Perfit CL
Manufacturer
Date Cleared
2023-06-20
(264 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Vatech mcis Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Perfit CL can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
Device Description
This medical device is used to color the zirconia pre- sintered body, and it is a color solution that makes the color similar to natural teeth by using a brush and immersion.
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