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510(k) Data Aggregation
K Number
K140877Device Name
VERICORE ZIRCONIA BLANKS
Manufacturer
WHIP MIX CORP.
Date Cleared
2014-09-03
(149 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
WHIP MIX CORP.
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 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-pressed and 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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K Number
K140146Device Name
COMFORTSOFT SOFT DENTURE LINER SYSTEM
Manufacturer
WHIP MIX CORP.
Date Cleared
2014-04-29
(97 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
WHIP MIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures.
Device Description
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures. Meets ISO 10139-2 and is a Shors A hardness Type A material. It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.
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