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510(k) Data Aggregation
K Number
K111291Device Name
AIDITE ZIRCONIA DENTAL CERAMICS
Manufacturer
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
Date Cleared
2011-07-20
(75 days)
Product Code
EIH, REG
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Device Description
Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.
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