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Found 3 results
510(k) Data Aggregation
K Number
K170596Device Name
TN-Brush
Manufacturer
GENOSS Co. Ltd.
Date Cleared
2017-09-11
(195 days)
Product Code
ELB
Regulation Number
872.4840Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.
Device Description
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K Number
K121114Device Name
TIGRAN PERIBRUSH
Manufacturer
TIGRAN TECHNOLOGIES AB
Date Cleared
2012-09-17
(158 days)
Product Code
ELB
Regulation Number
872.4840Why did this record match?
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Matched: '872.4840'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
Device Description
The Tigran™ PeriBrush™ is made of pure titanium (brush part) and nitinol (stem part). It is intended to use for mechanical debridement of surgically exposed dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis. The product has a connector that fits into the head (chuck) of a dental handpiece accepting instruments complying with ISO 1797-1. The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.
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K Number
K111724Device Name
STRAUMANN TIBRUSH
Manufacturer
STRAUMANN USA
Date Cleared
2011-09-12
(84 days)
Product Code
ELB
Regulation Number
872.4840Why did this record match?
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Matched: '872.4840'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Straumann® TiBrush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.
Device Description
The Straumann® TiBrush is made of Grade 5 Titanium and stainless steel for single patient use and is attached to a dental handpiece. It is used during open flap surgery to remove biofilms (plaque and calculus) from the surfaces of dental implants where the surface of the implant is exposed due to peri-implantitis. The TiBrush mechanically removes the biofilms from the surface of the implants without damaging the integrity of the roughened implant surface.
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