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510(k) Data Aggregation
K Number
K191133Device Name
KATANA Cleaner, KATANA Cleaner (Trial)
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2019-10-08
(162 days)
Product Code
PME, LBH
Regulation Number
872.3260Why did this record match?
Product Code :
PME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in.
- [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment
Device Description
This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in.
It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.
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K Number
K163171Device Name
CeraClean
Manufacturer
Bisco, Inc.
Date Cleared
2017-04-14
(151 days)
Product Code
PME
Regulation Number
872.3260Why did this record match?
Product Code :
PME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.
Device Description
CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.
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K Number
K152322Device Name
Resolve 2.0
Manufacturer
DENALI CORPORATION
Date Cleared
2015-12-16
(121 days)
Product Code
PME, LBH
Regulation Number
872.3260Why did this record match?
Product Code :
PME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
Device Description
Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
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