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510(k) Data Aggregation
K Number
K160203Device Name
ADAMANT ZIRCONIA DISC
Manufacturer
Date Cleared
2016-10-19
(265 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Adamant Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions.
Device Description
The ADAMANT ZIRCONIA DISC is a ceramic block, composed of partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) (Y-TZP) that can be cut/milled for forming dental restorations such as crowns and bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. The ADAMANT ZIRCONIA DISC is designed for milled production on commercial CAD/CAM systems. After milling the disc, it is final sintered, so the Zirconia Disc is transformed into the object as dental restorations.
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