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510(k) Data Aggregation
K Number
K000846Device Name
TKD SCALERS
Manufacturer
Date Cleared
2000-12-04
(264 days)
Product Code
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
ORASYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000848Device Name
TDK HANDPIECES
Manufacturer
Date Cleared
2000-10-05
(204 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ORASYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000847Device Name
ORALUBE
Manufacturer
Date Cleared
2000-09-27
(196 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ORASYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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