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510(k) Data Aggregation
K Number
K211308Device Name
INNI-CERA
Manufacturer
Date Cleared
2021-10-04
(158 days)
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Aon Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
INNI-CERA is indicated for use by dental technicians in the construction of custom made all ceramic restorations.
Coping
Crown
Inlay & Onlay
Veneer
Bridge(3-unit anterior bridges)
Device Description
INNI-CERA is intended for use in fabricating custom-made ceramic restorations using a 3D printer additive manufacturing process. It is a product that is used after fabricating and sintering with a mixture of zirconia powder and binder. The DLP 3D printer used to fabricate the INNICERA is a photocuring lamination method using an STL file (dental restoration shape), which is irradiated with light in the strong UV region (420nm) to cure the photocurable mixture to form a model. This product corresponds to ISO 6872 Type I Class III. The material is used in a 3D printer, which prints the shape determined by an STL file converted from patients' teeth data. 3D printer is not included with the product. INNI-CERA cannot be reused.
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