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510(k) Data Aggregation
K Number
K153546Device Name
PINK CAD/CAM disc
Manufacturer
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
Date Cleared
2016-09-28
(292 days)
Product Code
EBI, DAT
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Fabrication of dentures.
Device Description
PINK CAD/CAM disc are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in different pink shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
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K Number
K112967Device Name
PMMA CAD/CAM DISC
Manufacturer
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
Date Cleared
2012-08-28
(328 days)
Product Code
EBG, REG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
fabrication of temporary crowns and bridges
Device Description
PMMA CAD/CAM discs are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
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