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510(k) Data Aggregation
K Number
K130198Device Name
NEO DENTA ZIRCONIA
Manufacturer
Date Cleared
2013-10-21
(266 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
NEO GROUP LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Remedial Blanks for the Fabrication of Dental Restoration
Device Description
Neo Denta Zirconia is a partially sintered zirconia disc, which is vttrium oxide stabilized zirconium dioxide. The disc can be milled into various shapes of prostheses. A CAD/CAM system can be used to produce the prostheses needed from the blank. Neo Denta Zirconia provides an alternate to the gold, porcelain, ceramics and other types of material used in the dental laboratories for dental restoration.
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