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510(k) Data Aggregation
K Number
K182068Device Name
Erran Dental Zirconia
Manufacturer
Date Cleared
2018-12-13
(134 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Erran Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
Device Description
Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table 5-1, and are similar to the sizes and shapes of the predicate device.
There are two types of our device, one is block, another is powder. The main difference is that the blocks are made by powder, zirconia blocks is prepared and have a fixed shape, while zirconia powder is used to directly product the shape of the tooth.
Erran Dental Zirconia are derived from Zirconia powder that has been processed into their final net shapes. Erran Dental Zirconia have are then being further fabricated in to all-ceramic restoration such as crowns, bridge, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3 with its composition conforms to ISO13356-2015, Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia(Y-TZP). The performance of the dental zirconia conforms to ISO 6872-2015, Dentistry: Ceramic Materials.
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