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Found 3 results
510(k) Data Aggregation
K Number
K082158Device Name
DENSEO FAIRY
Manufacturer
Date Cleared
2008-10-15
(76 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
XPDENT CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Glaze used for the repair of check lines in PFMs and dental bridges.
Device Description
Not Found
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K Number
K071201Device Name
ZEO CE LIGHT & ZEO QUICK PORCELAIN
Manufacturer
Date Cleared
2007-07-30
(91 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
XPDENT CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Porcelain fused to metal for dental use.
Device Description
Not Found
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K Number
K061337Device Name
WIEDENT ESTETIC
Manufacturer
Date Cleared
2006-06-07
(26 days)
Product Code
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
XPDENT CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.
Device Description
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