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510(k) Data Aggregation
K Number
K172426Device Name
Clear Blue Digi LED Curing Light
Manufacturer
Date Cleared
2017-08-16
(6 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Promident LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Blue Digi LED curing light is a hand-held LED polymerization light intended to cure dental composites using visible light.
Device Description
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K Number
K080240Device Name
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
Manufacturer
Date Cleared
2008-02-07
(7 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PROMIDENT LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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