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510(k) Data Aggregation
K Number
K051796Device Name
CLEARFIL TRI-S BOND SINGLE DOSE
Manufacturer
KURARAY MEDICAL KURASHIKI PLANT
Date Cleared
2005-08-09
(35 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
KURARAY MEDICAL KURASHIKI PLANT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clearfil tri-S bond Single dose is indicated for the following applications:
1) Direct restorations using light cured composite resin
2) Cavity sealing as a pretreatment for indirect restorations
3) Treatment of exposed root surfaces
4) Core build-ups using light- or dual-cured composite resin
Device Description
This device is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips).
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K Number
K042929Device Name
ESTENIA C&B
Manufacturer
KURARAY MEDICAL KURASHIKI PLANT
Date Cleared
2004-12-06
(45 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
KURARAY MEDICAL KURASHIKI PLANT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.
1) Facing cast crowns and facing cast bridges
2) Jacket crowns
3) Inlays and onlays
4) Bridges with frameworks
Device Description
This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.
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