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510(k) Data Aggregation
K Number
K153767Device Name
X-cera Zirconia Blanks
Date Cleared
2016-03-29
(90 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Device Description
X-cera Zirconia Blanks are provided in either block, disc, cylinder shape and are derived from zirconia powder that has been processed via uni-axial die pressing, followed by iso-static pressing, to achieve final net shapes of uniform density and distribution. These Zirconia Blanks can be fabricated into various prosthetic dental device.
X-cera Zirconia Blanks are offered in ten(10) different product families of shapes and a multitude of different sizes as shown in Figure 1 and Table 1 and are capable of being machined into complex dental shapes using modern machining methods and are similar to the sizes and shapes of the predicate device.
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