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Found 6 results
510(k) Data Aggregation
K Number
K001481Device Name
PALCERAM 49Manufacturer
Date Cleared
2000-06-23
(43 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AUREX SA (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K001482Device Name
AURENORM 75 KFManufacturer
Date Cleared
2000-06-23
(43 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AUREX SA (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K001479Device Name
PALCERAM 53Manufacturer
Date Cleared
2000-06-21
(41 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AUREX SA (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K001480Device Name
AURECAST 40 BManufacturer
Date Cleared
2000-06-21
(41 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AUREX SA (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K001477Device Name
AURELUX Y 84 PREMIUMManufacturer
Date Cleared
2000-06-20
(40 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AUREX SA (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K001478Device Name
AURECAST SUPER INLAYManufacturer
Date Cleared
2000-06-20
(40 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AUREX SA (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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