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Found 4 results
510(k) Data Aggregation
K Number
K001914Device Name
CLEARFIL REPAIR
Manufacturer
KURARAY COMPANY, LTD.
Date Cleared
2000-08-10
(48 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
KURARAY COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001913Device Name
CLEARFIL ST OPAQUER
Manufacturer
KURARAY COMPANY, LTD.
Date Cleared
2000-08-04
(42 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
KURARAY COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K980232Device Name
CLEARFIL DC CEMENT
Manufacturer
KURARAY COMPANY, LTD.
Date Cleared
1998-02-24
(33 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
KURARAY COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1) Porcelain inlay cementation
- 2) Composite resin inlay cementation
- 3) Jacket crown cementation with porcelain or composite resin
Device Description
Not Found
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K Number
K965091Device Name
TEETHMATE F-1
Manufacturer
KURARAY COMPANY, LTD.
Date Cleared
1997-03-27
(98 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
KURARAY COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used as a sealing material for pit and fissure.
Device Description
This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.
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