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510(k) Data Aggregation
K Number
K201563Device Name
PuRE PMMA Disc
Manufacturer
Date Cleared
2021-04-09
(303 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Quest Dental USA Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.
Device Description
PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology. The discs are provided non-sterile, without any accessories, and are indicated for single use only. The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 Monochromatic colors and 20 multilayer colors all with varying thickness (14-40mm).
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K Number
K172281Device Name
PuRE PMMA Disc
Manufacturer
Date Cleared
2017-10-19
(83 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Quest Dental USA Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.
Device Description
PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology. The discs are provided non-sterile, without any accessories, and are indicated for single-use only.
The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 shades and varying thicknesses (14-30 mm).
Ask a Question
Ask a specific question about this device
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