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510(k) Data Aggregation
K Number
K130654Device Name
CRYSTAL ULTRA
Manufacturer
Date Cleared
2013-09-24
(196 days)
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns, and bridges.
For use by or on the order of a dental professional.
Device Description
The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
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