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510(k) Data Aggregation
K Number
K201492Device Name
Non-Sterile Zirconia Block
Manufacturer
Date Cleared
2021-03-10
(279 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Bioden Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-Sterile Zirconia Block (Model: Zircos-E ACE) is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Device Description
Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.
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K Number
K190139Device Name
Zircos-Com
Manufacturer
Date Cleared
2020-04-24
(451 days)
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Bioden Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Direct fillings of Class I to V restorations
- Shape and shade corrections
Device Description
Zircos-com is light-cured, radiopaque hybride composite resin. Zircos-Com is hybride composite resin for anterior and posterior restorations. Zircos-Com is reinforced filler composite.
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