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510(k) Data Aggregation
K Number
K203000Device Name
KeyPrint KeySplint Hard
Manufacturer
Mycone Dental Supply Co. Inc. (DBA Keystone Industries)
Date Cleared
2021-04-09
(190 days)
Product Code
MQC, EBI, KMY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Mycone Dental Supply Co. Inc. (DBA Keystone Industries)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KeyPrint® KeySplint Hard™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.
Device Description
KeyPrint® KeySplint Hard™ material is a UV-curable methacrylate-based resin, intended to be used by trained dental professionals for the 3D printing of various biocompatible dental devices such as mouthguards, splints, repositioners, and retainers. The printing of these devices is carried out using DLP printers utilizing pre-specified wavelengths. Each material is indicated for the fabrication of orthodontic and other dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the devices are 3D printed to create custom devices or appliances.
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