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510(k) Data Aggregation
K Number
K241729Device Name
Hard Splint & Thermo-Adaptive Splint
Manufacturer
Whip Mix Corporation
Date Cleared
2025-03-18
(277 days)
Product Code
MQC, KMY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Whip Mix Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Device Description
Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.
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K Number
K190107Device Name
VeriSplint
Manufacturer
Whip Mix Corporation
Date Cleared
2019-07-10
(169 days)
Product Code
MQC, EBI, MOC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Whip Mix Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
Device Description
The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.
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K Number
K152443Device Name
Vericore Gradient Temporary Disc
Manufacturer
WHIP MIX CORPORATION
Date Cleared
2016-05-11
(258 days)
Product Code
EBG, EGB
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
WHIP MIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.
Device Description
Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment.
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K Number
K142670Device Name
Vericore Zirconia Blanks
Manufacturer
WHIP MIX CORPORATION
Date Cleared
2014-10-22
(33 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
WHIP MIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;
- Zirconia Substructures .
- -Restorations (Including inlays, onlays, and veneers)
- . Crown Framework in the Anterior and Posterior regions
- . Bridge Framework in the Anterior and Posterior regions
Device Description
Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.
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