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510(k) Data Aggregation
K Number
K192153Device Name
Portux CAD/CAM Disc
Manufacturer
New Stetic S.A.
Date Cleared
2019-11-07
(90 days)
Product Code
EBG, EBI, MQC
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
New Stetic S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
- Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)
Device Description
The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.
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